A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults (NCT05319899), a randomized phase 1 study. The primary outcome is Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo).

2. Clinical Question

3. Trial Design

This was a phase 1, single-center, randomized, open-label, 3-period crossover study in healthy adults. The registry describes 3 treatments arranged across 6 possible sequences. In a crossover design, participants receive more than one study treatment during separate periods; here, the sequences varied the order in which participants received the regimens. This means the treatment groups in the outcome listing should not be read as three separate parallel groups of different people: the same participants could contribute measurements under more than one treatment.

The three regimens were ALXN1840 alone after an overnight fast; omeprazole with ALXN1840 after an overnight fast; and omeprazole with ALXN1840 in the fed condition. The record describes omeprazole dosing once daily in the morning on Days -5 to -1, followed by a dose at Hour -1 on Day 1. In the fed regimen, ALXN1840 was given approximately 30 minutes after the start of a meal. The dose amounts are not reported in the registry record.

The registry lists enrollment as 18 and reports 18 participants for each treatment’s primary outcome. The primary outcome was total plasma molybdenum AUC0-t, measured from predose through 192 hours postdose. The pharmacokinetic analysis population included participants completing at least 2 periods with sufficient data to determine pharmacokinetic parameters. The report does not state whether all enrolled participants met that definition beyond the listed group counts.

The study is marked completed. Its listed start date is 2014-01-20 and its primary completion date is 2014-03-24. The registry record does not report masking, consistent with the study being open-label, and does not describe a parallel-group design. A detailed original statistical analysis plan, including its treatment of period or sequence effects, is not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participants were randomized to one of 6 treatment sequences.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic (PK) analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: All enrolled participants.

Only the first 6 of 7 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo), measured over Predose (0 hour) up to 192 hours postdose.

The primary endpoint is the area under the plasma concentration versus time curve from time 0 to the last measurable concentration, abbreviated AUC0-t, for total molybdenum. Its unit is hours*ng/mL, and the stated timeframe is predose (0 hour) up to 192 hours postdose. The registry says AUC0-t was calculated using the linear trapezoidal method.

AUC summarizes concentration across a measurement interval. Rather than focusing on a single blood sample, it uses the series of concentrations over time to characterize overall exposure during the observed period. For this study, the measured substance was total molybdenum in plasma. The measure is therefore a pharmacokinetic endpoint, not a direct measure of symptoms, function, disease progression, or another clinical outcome.

Pharmacokinetic measures are used in studies like this to compare exposure under different administration conditions. Here, the comparisons address whether the posted exposure summaries differed when ALXN1840 was given alone or with omeprazole, and when the omeprazole regimen was paired with fed rather than fasted administration. Those are the questions the design and outcome address; the endpoint by itself does not establish a clinical consequence of any observed exposure difference.

The registry reports the endpoint as a mean with standard deviation for each treatment. It also posts geometric mean ratios for two comparisons. These summaries describe different aspects of the outcome: the arithmetic means and standard deviations describe the reported group distributions, while the ratios express one treatment’s geometric mean relative to another’s. The analysis details underlying the sponsor’s geometric mean ratios are not reported in the registry record.

7. Results Posted in the Registry

• Treatment B: Omeprazole + ALXN1840 (Fasted): mean 18,537 versus 14,531 on control; difference 4,006 (95% CI 254.87 to 7,757), standardized effect d = 0.70; z-test p = 0.036.
• Treatment C: Omeprazole + ALXN1840 (Fed): mean 14,536 versus 14,531 on control; difference 5.00 (95% CI -3,598 to 3,608), standardized effect d = 0.00; z-test p = 0.998.

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure and reports its mean and standard deviation by treatment. The outcome is AUC0-t for total plasma molybdenum, with the stated measurement interval running from predose to 192 hours postdose. A continuous outcome can take a range of numerical values. Its mean summarizes the central level of the observed measurements, and its standard deviation describes their spread around that mean. The standard deviation is not a confidence interval for the mean and does not itself show how precisely a treatment contrast has been estimated.

What does a mean difference say?

The posted recalculation compares the arithmetic mean for a treatment with the arithmetic mean for the reference treatment. A positive estimate means the first listed treatment’s reported mean is higher on this scale; an estimate near zero means the reported means are close. The recalculated comparison of fasted omeprazole plus ALXN1840 against fasted ALXN1840 alone is 4006.0 hours*ng/mL. The recalculated fed-regimen comparison against the fasted ALXN1840 reference is 5.0 hours*ng/mL. These are unadjusted recalculations from the posted summary statistics, not descriptions of the sponsor’s full analysis model.

A mean difference is expressed in the original outcome units, here hours*ng/mL. It therefore describes an absolute difference in arithmetic means. A ratio answers a different question by comparing relative geometric means. The two summaries can differ in both scale and interpretation, particularly when analysis uses a transformed outcome. The registry does not report the methods used to obtain the sponsor’s geometric mean ratios, so the calculations behind those estimates cannot be reconstructed from the record alone.

How should a confidence interval be read?

A confidence interval gives a range of estimates that are compatible with the data under the method used to construct it. It communicates uncertainty and precision around a point estimate; it is not a range containing a known fixed proportion of individual participants’ measurements. A narrower interval indicates greater precision than a wider interval on the same scale and under comparable methods. The mean-difference intervals shown with the recalculations are 95% intervals. The sponsor’s reported ratios have 90% confidence intervals. Those different confidence levels should be kept distinct when reading or comparing the intervals.

For the fasted omeprazole comparison, the recalculated mean-difference interval runs from 254.9 to 7757.0. For the fed regimen compared with fasted ALXN1840 alone, it runs from -3598.0 to 3608.0. The second interval spans zero, reflecting substantial uncertainty about the direction and size of the arithmetic mean difference. The interval should be read together with the point estimate and study context, rather than as a binary verdict about whether a treatment effect exists.

What does the p-value add?

The recalculated p-values are unadjusted: 0.036 for fasted omeprazole plus ALXN1840 versus fasted ALXN1840 alone, and 0.998 for the fed regimen versus the reference. In general, a p-value describes how unusual data at least as incompatible with a specified null model would be if that model were correct. It is not the probability that the null hypothesis is true, nor a measure of the size or clinical importance of a contrast. A p-value should not replace the estimate and its interval. The registry does not report an adjustment for making multiple comparisons, so the posted unadjusted values should not be interpreted as multiplicity-adjusted results.

The sponsor’s reported analyses are geometric mean ratios with 90% confidence intervals, but no p-values or method descriptions are posted for them. These are not the same analysis output as the unadjusted arithmetic mean-difference recalculations. The ratio for the fasted omeprazole comparison is 140.63, with a 90% interval from 118.94 to 166.26. The ratio comparing the two omeprazole regimens is 77.65, with a 90% interval from 65.67 to 91.80. The record does not report whether these ratios were derived from a particular transformation, model, or adjustment for crossover features.

Why does crossover structure matter?

In a crossover study, participants receive treatments in separate periods, and their measurements across treatments are related because they come from the same people. This structure can make within-participant comparisons informative. Treatment order, period, and potential carryover are among the general design considerations for crossover analyses. The registry record identifies the randomized sequences and periods, but it does not report the sponsor’s handling of these terms, any washout details, or the original analysis plan. Those details should not be inferred from the fact that the design was a crossover.

The recalculations use posted arm-level summary statistics and are described as simple unadjusted recalculations. They should not be mistaken for a reconstruction of a crossover model. The displayed standard deviations are marginal treatment summaries; the within-person covariance needed to reproduce a paired analysis is not reported. As a result, the recalculation does not capture all the information that may be used in an analysis of repeated measurements from the same participants.

The reported analysis population is also relevant. It includes participants who completed at least 2 periods and had sufficient data for pharmacokinetic parameter determination. How many participants were excluded from that population, how missing measurements were addressed, and how incomplete periods were treated are not reported in the registry record. These details affect how closely the analyzed data represent all enrolled participants.

Finally, the sample-size illustrations shown with the recalculations use the observed effect as their starting point. They are planning examples based on stated assumptions, not evidence that the trial had a particular probability of detecting an effect. The study’s original sample-size rationale and detailed statistical plan are not reported. For interpretation, the most direct evidence remains the posted outcome summaries, the estimates, and their confidence intervals, alongside the limitations of the design and registry reporting.

10. Confidence Intervals and Precision

Precision is about how much uncertainty surrounds an estimate. The treatment means alone do not show that uncertainty; the standard deviations describe variability among measurements, while the confidence intervals for contrasts describe uncertainty around the estimated comparison. Both are useful, but they answer different questions.

For the arithmetic mean difference between fasted omeprazole plus ALXN1840 and fasted ALXN1840 alone, the estimate is 4006.0 hours*ng/mL and the 95% confidence interval extends from 254.9 to 7757.0. The interval is consistent with a range of positive differences, but its breadth means the data do not pinpoint a single precise magnitude. The standard deviations for these two treatment summaries are 4303.0 and 6886.0, respectively.

For the fed omeprazole regimen compared with fasted ALXN1840 alone, the mean difference is 5.0 hours*ng/mL and its 95% confidence interval runs from -3598.0 to 3608.0. This interval includes zero and spans both negative and positive differences. It therefore leaves considerable uncertainty about the direction and size of the arithmetic-scale contrast. The observed mean difference near zero should not be read as proof that the regimens are equivalent. No equivalence margin or equivalence analysis is reported in the registry record.

The sponsor’s geometric mean ratio for fasted omeprazole plus ALXN1840 compared with ALXN1840 alone is 140.63, with a 90% confidence interval from 118.94 to 166.26. For omeprazole plus ALXN1840 in the fed condition compared with the fasted omeprazole regimen, the ratio is 77.65, with a 90% confidence interval from 65.67 to 91.80. These intervals have a different confidence level and a different scale from the recalculated mean-difference intervals. The record does not include the sponsor’s analysis method, so their construction cannot be assessed in detail.

Confidence intervals are estimates under their underlying statistical methods, not guarantees about the true value. Their width depends on data variability, sample size, and the method used. In this crossover study, within-participant data may matter for precision, but the correlation between repeated measurements is not reported. The posted group summaries alone cannot show how much that correlation contributed to the sponsor’s results.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size section translates an observed contrast into planning illustrations under explicit assumptions. All figures in the displayed planning table are participants per arm, not total event counts. The registry’s planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The figures are computed from the observed effect and are not the trial’s own original design assumptions; those original assumptions are not reported in the registry record.

The 80% power column describes the illustrative number of participants per arm for a design with an 80% chance of detecting the stated effect under the listed assumptions. The 90% power column gives the corresponding planning quantity for a 90% chance. These are planning concepts, not guarantees that a future study will produce a particular result. The figures are not observed power, and they do not change the interpretation of the completed study’s confidence intervals.

Rows that use 100%, 75%, or 50% of the observed effect illustrate how the planning result changes when the target effect is smaller than the one observed. Smaller effects need more participants to detect under otherwise similar assumptions. For the fed-regimen comparison, the observed mean difference is close to zero, and the resulting illustrations are extremely large. That pattern reflects the way these calculations scale from a very small observed effect; it should not be treated as a practical recommendation or as evidence about the true effect.

The table and associated curve are aids for reading the relationship between assumed effect size and sample size. They do not establish that the original trial was adequately powered, because the trial’s original sample-size justification and planned target effect are not reported. They also do not incorporate unreported features of the crossover analysis. Interpret these displays as hypothetical planning illustrations rather than as additional trial outcomes.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 4006.000; pooled standard deviation σ = 5741.638.
2. n = 2 × (1.96 + 0.842)² × 5741.638² / 4006.000² = 32.2, rounded up to 33 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 4006                      # observed difference in means
sigma <- 5741.63761482732                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5319899)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 33 (80% power), 44 (90% power)
 75% of observed effect: n per arm = 58 (80% power), 77 (90% power)
 50% of observed effect: n per arm = 129 (80% power), 173 (90% power)
power.t.test: 33.2 
Simulated power at n = 33 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Analyses Reported by the Sponsor

The registry reports two sponsor analyses as geometric mean ratios with 90% confidence intervals. For ALXN1840 alone compared with omeprazole plus ALXN1840 in the fasted condition, the posted ratio is 140.63, with an interval from 118.94 to 166.26. For omeprazole plus ALXN1840 in the fasted condition compared with the fed condition, the ratio is 77.65, with an interval from 65.67 to 91.80. The registry does not report p-values or the analysis methods for these ratios.

The recalculations shown alongside the results are unadjusted arithmetic mean differences derived from posted summary statistics. They answer a different question on a different scale from a geometric mean ratio. In addition, the published treatment means and standard deviations do not provide the within-participant covariance needed to reconstruct a paired crossover analysis. The recalculations should therefore be read as supplementary summaries, not as a replacement for the sponsor’s analysis.

The record indicates no discrepancy between the posted results and the recalculation. Even so, the two forms of analysis should not be conflated: the sponsor’s reported ratios are the registry’s own analysis results, while the mean differences are unadjusted re-calculations. The analysis details needed to assess how the sponsor accounted for treatment sequence, period, or repeated observations are not reported in the registry record.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and four analyses, but the posted primary outcome results include multiple treatment comparisons. The two recalculated mean-difference p-values are unadjusted. The registry record does not report whether the sponsor applied a multiplicity adjustment, specified a hierarchy for comparisons, or designated one contrast as the sole confirmatory comparison. Without those details, the p-values should be understood as unadjusted results rather than evidence adjusted for the number of comparisons.

The sponsor-reported geometric mean ratios have 90% confidence intervals, but the record does not describe their statistical model, adjustment strategy, or whether the intervals were intended for formal hypothesis testing. It also does not report p-values for these ratios. The confidence intervals can be read as the posted uncertainty summaries, while the missing method details limit assessment of how they were calculated.

The pharmacokinetic analysis population is defined as participants who completed at least 2 periods and had sufficient data to determine pharmacokinetic parameters. Each treatment outcome listing includes 18 participants, and enrollment is 18. The registry does not provide a participant flow account explaining completion, exclusions, or any difference between the enrolled group and the analysis population. It does not report how missing samples, incomplete periods, or measurements below a quantification limit were handled.

The design used randomized sequences in a 3-period crossover. The record does not report whether the analysis included period or sequence effects, how potential carryover was evaluated, or whether any washout interval was used. These are general considerations for crossover studies; their handling in this trial cannot be inferred from the design label alone. The original statistical analysis plan, the sample-size justification, and any interim analyses are not reported in the registry record.

These omissions do not invalidate the posted estimates, but they constrain independent evaluation of the analysis. In particular, group summaries cannot recover the repeated-measure relationships among participants, and the posted results do not show how the sponsor addressed missing data or multiplicity. Readers should distinguish clearly between what the registry reports and what remains undocumented.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 18 participants at risk of serious adverse events under each of the three treatment conditions. It records 0 participants affected by serious adverse events for ALXN1840 alone in the fasted condition, 0 for omeprazole plus ALXN1840 in the fasted condition, and 0 for omeprazole plus ALXN1840 in the fed condition. No serious adverse event terms are listed in the posted summary.

These figures describe the serious adverse event counts shown in the registry for this study. They should not be interpreted as evidence that serious events are impossible or that the regimens have been established as safe. The study enrolled a small group of healthy participants and reports a limited observation context. The registry’s death figures are not reported, so no conclusion about deaths can be drawn from that field.

The record separately lists participants with other, non-serious adverse events: 6 under the fasted ALXN1840 condition, 5 under fasted omeprazole plus ALXN1840, and 6 under fed omeprazole plus ALXN1840. These are counts of participants affected, not counts of individual event episodes. The available summary does not provide event descriptions or further detail about severity, timing, or relatedness. The serious-event figures and other adverse-event counts should be read as separate categories.

16. What the Result Does, and Does Not, Mean

This study’s primary outcome is a measure of total plasma molybdenum exposure after single-dose ALXN1840 regimens. The posted means and comparisons describe that pharmacokinetic question in healthy adults. They do not directly measure a clinical outcome, and the registry record does not report patient-centered outcomes or evidence about effects in people with a health condition.

The arithmetic summaries show a higher mean AUC0-t for fasted omeprazole plus ALXN1840 than for fasted ALXN1840 alone, with a recalculated mean difference of 4006.0 hours*ng/mL. The 95% confidence interval ranges from 254.9 to 7757.0. For the fed omeprazole regimen compared with fasted ALXN1840 alone, the recalculated mean difference is 5.0 hours*ng/mL, with a 95% interval from -3598.0 to 3608.0. These estimates and intervals describe the posted data on the arithmetic mean scale; they do not establish the clinical importance of either contrast.

The second interval includes zero and is broad, so it does not establish that the fed and reference regimens have identical exposure. Nor does a point estimate near zero establish equivalence. An equivalence conclusion would require an appropriate design and a prespecified margin, neither of which is reported in the registry record. The geometric mean ratios add another summary of exposure, but their analysis method is not described in the record and they should not be substituted for the arithmetic contrasts.

Because the study is a randomized crossover, each participant’s treatment order and repeated measurements are part of the design. However, the posted summary does not show the within-participant data or the sponsor model. The registry also does not report a detailed missing-data strategy, multiplicity plan, or original sample-size rationale. These gaps limit how fully the posted results can be independently assessed.

The results should therefore be interpreted narrowly: they report exposure summaries under three administration conditions in a small healthy-participant study. They do not establish how any difference in plasma molybdenum translates into clinical benefit, risk, or treatment choice. No medical recommendation follows from these results alone.

17. Why This Trial Matters Statistically

The study illustrates why a crossover design can be useful for pharmacokinetic questions: the same participants receive multiple regimens in different periods, allowing exposure under different conditions to be examined within a randomized sequence structure. At the same time, crossover results depend on how repeated observations, order, and period are handled. The registry identifies the design and sequences but does not report the sponsor’s model details. That makes the distinction between the design and the available statistical description especially important.

It also demonstrates that summaries on different scales can tell different statistical stories. The posted arithmetic means and recalculated mean differences use the original AUC units. The sponsor’s geometric mean ratios express relative comparisons and have 90% confidence intervals. Neither representation should be treated as a simple restatement of the other. Analysts and readers need to identify the estimand and scale before interpreting a result.

The precision information is as important as the point estimates. The interval around the fed-regimen mean difference is wide and includes values in either direction, while the interval for the fasted omeprazole contrast is also broad despite lying above zero. Those intervals show why a single estimate or p-value is not enough to communicate what the study can establish.

Finally, the sample-size illustrations are not a substitute for the original design rationale. They show how hypothetical planning requirements vary with an assumed fraction of the observed effect, under stated assumptions. The registry does not report the trial’s original sample-size justification. This is a useful reminder to keep retrospective planning exercises separate from prospective design choices and from observed evidence.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The record gives a limited statistical account of a randomized, 3-period crossover study. It does not report the sponsor’s full analysis model, including whether treatment period, sequence, or within-participant dependence was accounted for. The posted arithmetic recalculations use treatment-level summary statistics and cannot recreate a paired crossover analysis without the participant-level relationship between measurements.

The primary analysis population is defined by completion of at least 2 periods and sufficient pharmacokinetic data, but the record does not describe participant flow or explain exclusions. It does not report how incomplete periods or missing pharmacokinetic samples were handled. The enrolled count and treatment-level counts are listed as 18, but the record does not give a detailed account of data availability by period.

The sponsor’s geometric mean ratio analyses are reported without method descriptions or p-values. The record does not state whether the confidence intervals account for multiple comparisons, and the recalculated p-values are unadjusted. It also does not provide the original statistical analysis plan, the trial’s own sample-size assumptions, or whether interim analyses occurred. These aspects should not be inferred.

The study involved healthy adults at a single center, and its primary measure is pharmacokinetic exposure. The record does not establish how the results apply to other populations or translate into clinical outcomes. It gives no dose amounts in the arm descriptions. Serious adverse event counts are listed, but the safety summary does not provide event-level detail or death counts.

Finally, the displayed planning illustrations are derived from observed effects under stated assumptions, not from a documented prospective sample-size rationale. The very large illustrations for the comparison with a near-zero observed mean difference should be viewed as a feature of that calculation, not as a direct statement of what a future study must enroll.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults — NCT05319899.
• Registry record last updated 2023-08-01; status last verified 2022-09.
• Results first posted 2023-08-01.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT05319899 is a completed phase 1, randomized, open-label, single-center, 3-period crossover study in healthy adults. It compares single-dose ALXN1840 administered fasted, with omeprazole while fasted, and with omeprazole in the fed condition. Enrollment is listed as 18.

The primary outcome is total plasma molybdenum AUC0-t, measured from predose through 192 hours postdose and calculated by the linear trapezoidal method. The registry reports treatment means and standard deviations, two sponsor-reported geometric mean ratios with 90% confidence intervals, and recalculated arithmetic mean differences with 95% confidence intervals.

The posted results describe pharmacokinetic exposure, not clinical outcomes. Detailed analysis methods, multiplicity handling, missing-data procedures, and the original sample-size justification are not reported in the registry record. The estimates should be read with their uncertainty and with the limitations of the registry’s statistical detail.