This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants (NCT06831344), a randomized phase 1 study. The primary outcome is Maximum Observed Drug Concentration (Cmax) of Vonoprazan.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06831344 |
| Phase | Phase 1 |
| Condition | Healthy Volunteers |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | 5 |
| Lead sponsor | Phathom Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Healthy participants enrolled in a Phase 1 pharmacokinetic study. The registry reports an enrollment of 25 and defines the pharmacokinetic population as participants who received at least one dose and had sufficient concentration data to estimate at least one pharmacokinetic parameter accurately.
Intervention
The study evaluated two vonoprazan orally disintegrating tablet formulations, described as administered without water or mixed with water and administered via a syringe. The registry lists treatments A through E, but the available arm descriptions do not fully map those labels to the administration methods.
Comparator
The intended reference was the vonoprazan tablet. The posted primary comparisons use treatment labels A through E; the registry’s reported analyses compare selected label pairs. The precise mapping of every label to formulation and administration method is not reported in the registry record.
Primary question
After a single oral dose, how did the maximum observed plasma concentration of vonoprazan compare across the listed treatments? The study’s stated objective was to assess bioavailability of the two orally disintegrating formulations relative to the vonoprazan tablet. The posted primary endpoint is Cmax, a measure of peak observed concentration, rather than a clinical benefit outcome.
3. Trial Design
This was a Phase 1, randomized, open-label, single-dose, five-period crossover study in healthy participants. The registry reports 25 enrolled participants and a completed study. Participants were randomly assigned to one of five treatment sequences, with the sequence allocation described as 1:1:1:1:1. The treatment descriptions identify five labels, A through E, each associated with vonoprazan 10 mg.
In a crossover design, participants receive different study treatments across periods rather than remaining in a single treatment group throughout. This allows comparisons to draw on measurements made under multiple treatments within the same participant, which can reduce the influence of stable differences between participants. That is a general feature of crossover designs; the registry record does not report the statistical model used to account for the crossover structure.
The listed dosing schedule places treatment on the first day of each three-day period. Pharmacokinetic sampling was scheduled from within 15 minutes before dosing through 48 hours after dosing. The study was open-label, so masking is not reported as part of the design. The record describes the purpose as assessing bioavailability, not comparing symptom outcomes or clinical effectiveness.
The registry’s brief objective describes two orally disintegrating tablet formulations administered either without water or mixed with water and given via a syringe, relative to a vonoprazan tablet. However, the available arm descriptions are incomplete, and the treatment-label mapping to each formulation and administration method is not reported in the registry record. Details such as washout procedures, the planned handling of period or sequence effects, and the sample-size justification are also 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: A total of 25 healthy participants were enrolled in this 5-period crossover study and were randomized to 1 of 5 treatment sequences to receive vonoprazan as two formulations (orally dispersible tablet \[ODT\]-1 and ODT-2) with or without water. The reference formulation was vonoprazan 10 milligram (mg) tablets (Treatment E).
Overall Study
| Stage | Vonoprazan 10 mg: Treatment Sequence 1 | Vonoprazan 10 mg: Treatment Sequence 2 | Vonoprazan 10 mg: Treatment Sequence 3 | Vonoprazan 10 mg: Treatment Sequence 4 | Vonoprazan 10 mg: Treatment Sequence 5 |
|---|---|---|---|---|---|
| STARTED | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Pharmacokinetic (PK) population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
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: The safety population included all participants who receive at least 1 dose of study drug. As planned, baseline data was collected and reported as single arm for all 25 participants.
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 25 | |
| Age, Continuous | years | 37.2 (SD 8.66) |
| Sex: Female, Male: Female | Participants | 15 |
| Sex: Female, Male: Male | Participants | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 19 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 16 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Observed Drug Concentration (Cmax) of Vonoprazan, measured over Day 1 of each 3-day treatment period: Within 15 minutes pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanogram per milliliter (ng/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the maximum observed plasma concentration of vonoprazan, abbreviated Cmax, measured in nanograms per milliliter. Blood sampling was scheduled within 15 minutes before dosing and at multiple post-dose times through 48 hours on the first day of each treatment period. Cmax is the highest measured concentration in that sampling profile. It is used in pharmacokinetic comparisons because it describes the observed peak exposure after dosing.
The registry reports Cmax as a geometric mean with geometric coefficient of variation. A geometric mean is a way of summarizing positive measurements on a multiplicative scale; it is often used for concentration data that vary proportionally rather than by equal absolute amounts. The geometric coefficient of variation describes relative variability on that scale. These are general statistical interpretations of the reported summary measures.
For the primary endpoint, the posted comparisons are ratios of geometric least-squares means, expressed as percentages, with 90% confidence intervals. A ratio near 100% indicates that the compared geometric means are close in relative terms. The interval communicates uncertainty around that ratio. Cmax is one aspect of bioavailability, but the endpoint alone does not describe the full concentration-time profile or establish a clinical effect. The registry record’s primary endpoint description reports Cmax; it does not report a clinical outcome endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted Cmax summaries show geometric means from 5.4 to 6.11 ng/mL across treatments A through E. The geometric coefficients of variation range from 36.1 to 47.8. These summaries describe the observed peak concentrations and their relative variability; they are not, by themselves, adjusted treatment comparisons.
The registry reports six pairwise ratios with 90% confidence intervals. For treatment A relative to E, the ratio is 113.26%, with a 90% interval from 104.86% to 122.33%. For B relative to E, it is 107.65% (99.67% to 116.28%); for C relative to E, 101.19% (93.68% to 109.30%); and for D relative to E, 105.94% (98.08% to 114.43%). The other reported comparisons are A relative to B at 95.05% (88.00% to 102.67%) and C relative to D at 104.69% (96.93% to 113.08%). These are the registry’s reported comparisons, and their treatment-label mapping should not be extended beyond what the record identifies.
The point estimates describe relative geometric mean Cmax. The intervals show that the estimates are not exact and indicate a range of values compatible with the reported analysis. A confidence interval is not a guarantee that the true value lies inside the interval, nor does it state the probability that a particular value is true. That is general interpretation of confidence intervals.
The registry classifies these analyses as equivalence comparisons, but the equivalence margin and decision criteria are not reported in the registry record. Consequently, the interval estimates can be described, but a conclusion that a comparison met a specific equivalence criterion cannot be independently checked from the recorded information. The primary results also do not report p-values.
These findings concern pharmacokinetic measurements following single doses in healthy participants. They do not establish how the formulations compare for clinical outcomes, repeated use, or other populations. The Cmax data should be read as estimates of peak concentration and uncertainty, not as evidence of clinical benefit or harm.
9. Statistical Methods Explained
The registry presents the primary endpoint as a geometric mean and geometric coefficient of variation, then reports selected comparisons as ratios of geometric least-squares means with 90% confidence intervals. The record does not identify the full statistical model, the covariates used, or the exact calculation procedure for those primary comparisons. The concepts below explain how to read the reported summaries in general; they should not be taken as a reconstruction of an unreported analysis plan.
What does a geometric mean summarize?
A geometric mean is calculated on a logarithmic scale and then expressed back on the original scale. This makes it suitable for positive measurements whose variation is more naturally understood proportionally. For example, a multiplicative increase and a corresponding multiplicative decrease can be treated symmetrically on the log scale. Plasma concentrations are positive measurements, so a geometric summary can be informative when values vary by relative rather than fixed absolute amounts.
The geometric coefficient of variation is a relative measure of dispersion. It is not the same as a standard deviation measured in the original concentration units. Larger values indicate more relative variability in the observations. The registry reports this measure for the primary endpoint, but does not provide individual participant values or primary-endpoint confidence intervals for each treatment’s geometric mean.
How should the reported ratios be read?
A ratio of geometric least-squares means compares model-based geometric means for two treatments. The registry expresses the ratios as percentages. A value of 100% would represent equal geometric means; values above or below that point indicate a higher or lower estimated geometric mean for the first listed treatment relative to the second, according to the comparison. The ratio is a relative contrast, not an absolute difference in concentration.
A confidence interval communicates the precision of the estimated ratio under the analysis used. A narrower interval indicates greater precision than a wider interval, all else equal. The 90% intervals reported for the primary comparisons should be interpreted together with the prespecified decision criteria. The equivalence margin and related criteria are not reported in the registry record, so the intervals alone do not establish whether a formal equivalence rule was satisfied.
What does the crossover design contribute?
In general, crossover studies compare treatments within participants, which can help control for participant characteristics that remain stable across treatment periods. That advantage depends on the design and analysis accounting appropriately for period, sequence, and possible carryover effects. The registry reports a five-period crossover and randomized treatment sequences, but the detailed model and the handling of those effects are not reported in the registry record. Therefore, the posted estimates should be read as the reported results, without assuming a particular adjustment method.
How do the recalculated secondary comparisons differ?
The displayed secondary comparisons are labelled recalculated. They are simple, unadjusted re-calculations from posted summary statistics, rather than the sponsor’s reported analyses. For the listed secondary outcomes, these comparisons use mean differences and confidence intervals. A mean difference expresses an absolute contrast in the outcome’s original units, unlike the relative ratio used for primary Cmax. The associated p-values are unadjusted. They do not account for the number of endpoints or comparisons examined, and the registry record does not report sponsor analyses for those secondary comparisons.
Those recalculations are useful as descriptive checks of the posted summaries, but they are not a substitute for the sponsor’s analysis, particularly in a crossover setting where participant-level data and the planned model matter. The secondary endpoints are not reduced to one comparison: the available recalculations cover selected treatment contrasts only. The registry record does not report recalculated comparisons for every treatment pair or every listed secondary endpoint.
What do the planning illustrations mean?
The sample-size illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They show hypothetical participants per arm for 80% or 90% power under specified fractions of an observed effect. They are planning illustrations based on the observed effect, not the trial’s design justification and not observed power. The registry record does not report the trial’s own sample-size justification. Planning figures based on an estimated effect can vary substantially if the true effect differs from that estimate, so they should not be treated as a forecast of a future study’s result.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Ratio of GLSM Percentage (%) 113.26 | 104.86 to 122.33 | not reported |
| not stated | Ratio of GLSM (%) 107.65 | 99.67 to 116.28 | not reported |
| not stated | Ratio of GLSM (%) 101.19 | 93.68 to 109.30 | not reported |
| not stated | Ratio of GLSM (%) 105.94 | 98.08 to 114.43 | not reported |
| not stated | Ratio of GLSM (%) 95.05 | 88.00 to 102.67 | not reported |
| not stated | Ratio of GLSM (%) 104.69 | 96.93 to 113.08 | not reported |
The primary Cmax ratios and 90% confidence intervals are registry-reported analyses. They are distinct from the recalculated comparisons presented for selected secondary outcomes. The recalculations use posted summary statistics and are simple, unadjusted contrasts; they do not reproduce the sponsor’s primary analysis or its model.
The registry labels the primary comparisons as equivalence analyses. Their point estimates and intervals provide the reported relative Cmax results, but the equivalence margin and decision criteria are not reported in the registry record. Without those criteria, the numerical intervals can be described but not independently judged against the intended formal rule.
No discrepancy between the posted primary result and a recalculated primary result is indicated, and no recalculated primary result is reported. The secondary recalculations should therefore be understood as supplementary descriptive calculations, not as an alternative to the sponsor’s own analysis. For the primary endpoint, the sponsor’s reported analysis is the relevant analysis available in the registry record. The treatment-label mapping to the particular ODT administration methods is incomplete in the available arm descriptions, so the comparisons should remain identified by their treatment labels.
11. Multiplicity, Missing Data and Analysis Populations
The registry record does not report how multiplicity was handled across the primary comparisons, secondary outcomes, or treatment contrasts. Multiplicity matters when several hypotheses are examined: even when each test uses a conventional threshold, the chance of at least one apparently unusual result across a collection of tests can increase. That is a general statistical concern, not a claim about the study’s unreported plan.
The primary endpoint has several reported pairwise comparisons, each with a 90% confidence interval, and no primary p-values are posted. The record classifies these comparisons as equivalence analyses, but does not report the equivalence margin, the testing sequence, or whether any adjustment was used. The secondary recalculations have unadjusted p-values and should be treated cautiously because they do not account for multiple endpoints or contrasts. A prespecified multiplicity strategy is not reported in the registry record.
Missing-data handling is also not reported in the registry record. The primary endpoint population is defined as participants who received at least one dose and had sufficient concentration data to support accurate estimation of at least one pharmacokinetic parameter. The record does not give endpoint-specific analysis counts, describe how missing samples were handled, or state whether any observations were excluded from particular analyses. The posted arm summaries report 25 for each treatment, but that does not explain the completeness of each participant’s concentration profile.
For a crossover study, missing measurements can affect the available within-participant comparisons, and the consequences depend on the pattern and analysis method. The statistical model, handling of period or sequence effects, and treatment of any carryover are not reported in the registry record. The record also does not report whether interim analyses were planned or conducted. These omissions limit independent assessment of the analysis process; they do not establish that any particular method was or was not used.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Treatment A: Vonoprazan 10 mg | 0 | 25 | 0.0% |
| Treatment B: Vonoprazan 10 mg | 0 | 25 | 0.0% |
| Treatment C: Vonoprazan 10 mg | 0 | 25 | 0.0% |
| Treatment D: Vonoprazan 10 mg | 0 | 25 | 0.0% |
| Treatment E: Vonoprazan 10 mg | 0 | 25 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment A: Vonoprazan 10 mg | 0 of 25 |
| Treatment B: Vonoprazan 10 mg | 0 of 25 |
| Treatment C: Vonoprazan 10 mg | 0 of 25 |
| Treatment D: Vonoprazan 10 mg | 0 of 25 |
| Treatment E: Vonoprazan 10 mg | 0 of 25 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment A: Vonoprazan 10 mg | 2 of 25 |
| Treatment B: Vonoprazan 10 mg | 0 of 25 |
| Treatment C: Vonoprazan 10 mg | 1 of 25 |
| Treatment D: Vonoprazan 10 mg | 1 of 25 |
| Treatment E: Vonoprazan 10 mg | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment A: Vonoprazan 10 mg | Treatment B: Vonoprazan 10 mg | Treatment C: Vonoprazan 10 mg | Treatment D: Vonoprazan 10 mg | Treatment E: Vonoprazan 10 mg |
|---|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | 1 of 25 | 0 of 25 | 1 of 25 | 0 of 25 | 0 of 25 |
| Nausea | Gastrointestinal disorders | 0 of 25 | 0 of 25 | 0 of 25 | 0 of 25 | 1 of 25 |
| Vomiting | Gastrointestinal disorders | 0 of 25 | 0 of 25 | 0 of 25 | 0 of 25 | 1 of 25 |
| Dizziness | Nervous system disorders | 1 of 25 | 0 of 25 | 0 of 25 | 0 of 25 | 0 of 25 |
| Dry skin | Skin and subcutaneous tissue disorders | 0 of 25 | 0 of 25 | 0 of 25 | 1 of 25 | 0 of 25 |
| Erythema | Skin and subcutaneous tissue disorders | 0 of 25 | 0 of 25 | 0 of 25 | 1 of 25 | 0 of 25 |
The registry reports zero serious adverse events and zero deaths for each of treatments A through E. It reports other adverse events affecting 2 participants for treatment A, 0 for treatment B, and 1 each for treatments C, D, and E. These are the posted counts by treatment label.
The study is a crossover, so participants could contribute experience under more than one treatment. The treatment-specific counts should not be added to infer a total number of different participants affected. The registry record does not provide event terms for the other adverse events in the available summary, and the serious-event term list is empty. It also does not report enough detail to assess event timing, severity beyond the serious/non-serious distinction, or attribution to treatment.
Zero recorded serious events in these treatment groups is a description of the posted safety data, not proof that serious events cannot occur. The study enrolled healthy participants and evaluated single-dose administration; its safety counts do not by themselves characterize risks with repeated use or in other populations. They should be read as limited observations from this study, rather than as a definitive safety assessment.
13. What the Result Does, and Does Not, Mean
The primary result describes relative peak vonoprazan concentrations across the treatment labels reported in the registry. The ratios and confidence intervals indicate the estimated relative Cmax values and their statistical uncertainty. They do not directly measure symptom improvement, disease control, or another clinical outcome. The study’s stated objective is bioavailability, and the posted primary endpoint is pharmacokinetic.
The registry labels the primary analyses as equivalence comparisons, but the equivalence margin and decision criteria are not reported in the registry record. A ratio near 100% does not by itself establish equivalence. That conclusion depends on the interval and a prespecified acceptable range, along with the analysis plan. The reported confidence intervals can be interpreted as estimates of precision, but the missing decision criteria prevent an independent check of the formal equivalence conclusion.
The data also do not establish that the formulations have the same effects in clinical use. The study enrolled healthy participants, assessed single-dose administration, and measured drug concentrations. The registry record does not report clinical efficacy outcomes for this study. Nor should the selected secondary recalculations be treated as confirmatory: they are unadjusted, cover selected contrasts, and do not reproduce a reported sponsor model.
The findings are therefore best understood as a set of pharmacokinetic estimates in the study’s defined setting. They can inform how the observed peak concentrations and selected secondary measures compare, with the uncertainty described by the reported intervals. They cannot, on their own, answer questions about repeated dosing, other populations, clinical outcomes, or a formal equivalence margin that is absent from the registry record.
14. Why This Trial Matters Statistically
This trial illustrates why pharmacokinetic interpretation depends on both the endpoint and the comparison method. Cmax summarizes a peak concentration, while the registry reports it using geometric means and relative ratios. The appropriate reading is therefore in terms of relative exposure estimates and uncertainty, rather than an absolute clinical effect.
The crossover structure is also statistically important. In general, comparing treatments within participants can reduce the influence of stable between-participant variation. At the same time, valid interpretation depends on how the analysis handles period, sequence, and possible carryover effects. Those details are not reported in the registry record, making it important to distinguish the posted results from assumptions about the model.
Equivalence language requires particular care. A set of point estimates near 100% is not enough to establish equivalence; the confidence interval must be evaluated against a prespecified margin. Because that margin and the decision criteria are not reported, readers can describe the observed ratios and intervals without claiming that a formal equivalence standard was met.
Finally, the posted secondary calculations show the difference between a useful descriptive re-calculation and a trial’s own inferential analysis. Simple contrasts from summary data can help readers understand the scale and uncertainty of selected results, but they do not replace participant-level analysis or account for multiplicity. Keeping those distinctions clear helps prevent exploratory numbers from being interpreted as definitive findings.
15. 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 registry record leaves several details needed for a full independent appraisal unreported. The treatment descriptions name five labels, but the available arm descriptions do not fully identify which label corresponds to each formulation and administration method. This restricts interpretation of label-to-label comparisons in terms of the specific ODT method.
The equivalence margin, statistical model, covariates, handling of period and sequence effects, and approach to possible carryover are not reported in the registry record. Missing-data procedures and endpoint-specific analysis counts are also not reported. The record defines the pharmacokinetic population, but does not provide enough detail to assess the completeness of each concentration profile or the consequences of missing samples.
The posted secondary recalculations are limited: they use summary statistics, are unadjusted, and cover selected comparisons. Sponsor analyses for those secondary comparisons are not reported in the registry record. Numerical results for some listed secondary outcomes are also not reported. The multiplicity plan for the primary and secondary comparisons is not reported, which limits interpretation of multiple intervals and unadjusted p-values.
External interpretation is constrained by the study setting: healthy participants received single doses, and the primary endpoint is a pharmacokinetic measure. The posted results do not address clinical outcomes or repeated use. The record also does not report the sample-size justification, so the enrollment cannot be independently related to a prespecified precision or power target. These limitations do not negate the recorded estimates, but they narrow the conclusions that can be drawn from them.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants — NCT06831344.
- Registry record last updated 2025-12-19; status last verified 2025-12.
- Results first posted 2025-12-19.
- 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.
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19. Record Summary
The registry record describes a completed Phase 1, randomized, open-label, five-period crossover study of single-dose vonoprazan in healthy participants. The stated objective was to assess bioavailability for two orally disintegrating tablet formulations relative to the vonoprazan tablet. Enrollment was 25.
The primary endpoint was maximum observed plasma concentration, reported as geometric means and geometric coefficients of variation, with selected treatment ratios and 90% confidence intervals. The registry classifies the reported comparisons as equivalence analyses, but the equivalence margin and decision criteria are not reported. Secondary outcomes include additional pharmacokinetic measures; numerical results are available for only some, with selected unadjusted recalculations.
Zero serious adverse events and zero deaths are reported for each treatment label. Other adverse events were reported by treatment label. The available record supports interpretation of single-dose pharmacokinetic estimates in healthy participants, but does not report key details of the statistical model, multiplicity approach, or missing-data handling.