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 Compare Two Different Formulations of Lasmiditan in Healthy Participants (NCT04881747), a randomized phase 1 study. The primary outcome is Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04881747 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 47 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy participants were enrolled. The registry reports enrollment of 47 and defines the primary pharmacokinetic population as participants who received at least one dose of lasmiditan and had evaluable pharmacokinetic data. The arm summaries list 46 participants for the immediate-release condition, 46 for the oral-disintegrating tablet without water, and 44 for the oral-disintegrating tablet with water. The registry does not describe the demographic characteristics of participants in the information.
Intervention
The test treatment was 100 mg lasmiditan as an oral-disintegrating tablet. It was administered either without water or with water. The study also assessed adverse effects and tolerability of the oral-disintegrating formulation, according to the registry summary.
Comparator
The reference treatment was 100 mg lasmiditan as an orally administered immediate-release tablet. The registry describes the study as a comparison of the oral-disintegrating tablet with the current immediate-release formulation.
Primary question
The primary endpoint was maximum plasma concentration of lasmiditan, expressed in nanograms per milliliter. The pharmacokinetic question was whether exposure after the oral-disintegrating tablet, with or without water, could be compared with exposure after the immediate-release tablet. The registry also reports ratios of geometric least-squares means with 90% confidence intervals. It does not report an equivalence margin in the information available, so the comparison estimates alone do not establish whether a prespecified equivalence criterion was met.
This is a pharmacokinetic formulation study rather than a trial of migraine symptom relief. Its stated focus is how much lasmiditan enters the bloodstream and how long the body takes to eliminate it. The primary result concerns the highest measured concentration after dosing; it does not directly measure symptom change, duration of migraine relief, or comparative clinical benefit.
3. Trial Design
The registry identifies this as a phase 1, randomized, unmasked crossover study in healthy participants. It was sponsored by Eli Lilly and Company and is listed as completed. Enrollment was 47. The registry gives the study start as 2021-05-14 and primary completion as 2021-07-24. It describes the planned participant experience as about 5 weeks, including screening, with screening required within 28 days before the start of the study.
Three treatment conditions are described: 100 mg lasmiditan immediate-release tablet as the reference, 100 mg oral-disintegrating tablet without water, and 100 mg oral-disintegrating tablet with water. In a crossover design, treatment conditions are compared through repeated treatment periods rather than treating each treatment group as necessarily independent. This structure can make within-participant comparisons informative because each participant's measurements can be considered in relation to that participant's measurements under another condition. The actual treatment sequences, period schedule, washout details, and allocation procedure are not reported in the registry record.
The primary outcome is pharmacokinetic: maximum concentration of lasmiditan. Blood concentration measurements were scheduled from predose through 120 hours post-dose, including measurements at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose. The registry summarizes the endpoint using geometric means and geometric coefficients of variation. It also reports comparisons as ratios of geometric least-squares means.
The arm summaries list 46 participants for immediate-release, 46 for oral-disintegrating without water, and 44 for oral-disintegrating with water. These arm counts should not be added to infer the number of people in the crossover study: the same participant may contribute data under more than one treatment condition. The registry does not report the treatment sequence counts or the number with evaluable data for each specific comparison.
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: Crossover study with three study periods, each participant received immediate release (IR) tablet as reference; oral disintegrating (OD) tablet with water and without water as test doses of 100 milligram (mg) lasmiditan according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 5 days.
Period 1
| Stage | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 7 |
| Received At Least One Dose of Study Drug | 8 | 8 | 8 | 8 | 8 | 7 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period 1 Washout
| Stage | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 7 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period 2
| Stage | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 7 |
| Received At Least One Dose of Study Drug | 8 | 8 | 8 | 8 | 8 | 7 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period 2 Washout
| Stage | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 7 |
| COMPLETED | 6 | 8 | 8 | 7 | 7 | 7 |
| NOT COMPLETED | 2 | 0 | 0 | 1 | 1 | 0 |
Reasons for not completing this period:
| Reason | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| Adverse Event | 1 | 0 | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
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.
| Characteristic | Unit | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|---|
| Participants analysed | 8 | 8 | 8 | 8 | 8 | 7 | |
| Age, Continuous | years | 40.6 (SD 13.3) | 35.6 (SD 12.5) | 40.6 (SD 14.3) | 35.8 (SD 12.6) | 43.5 (SD 11.5) | 47.3 (SD 12.5) |
| Sex: Female, Male: Female | Participants | 2 | 3 | 4 | 2 | 3 | 2 |
| Sex: Female, Male: Male | Participants | 6 | 5 | 4 | 6 | 5 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 2 | 1 | 2 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 6 | 6 | 7 | 6 | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 1 | 1 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 4 | 5 | 4 | 4 | 2 |
| Race (NIH/OMB): White | Participants | 3 | 4 | 3 | 3 | 3 | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 8 | 8 | 8 | 8 | 8 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan, measured over Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanograms per milliliter (ng/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum concentration, or Cmax, of lasmiditan in blood after a dose. Concentration was measured in nanograms per milliliter. The registry describes the summary statistic as a geometric mean and reports geometric coefficient of variation as the measure of dispersion. The measurement schedule begins at predose and extends through 120 hours post-dose.
Cmax is used in pharmacokinetic studies because it captures the peak observed concentration after administration. Comparing peak concentrations across formulations helps characterize whether the formulations produce similar systemic exposure patterns. This is relevant when a new formulation is intended to provide the same drug by a different delivery form, as in the comparison of the oral-disintegrating tablet with the immediate-release tablet.
General statistical explanation: concentration measurements are often positively skewed, so pharmacokinetic analyses commonly work on a logarithmic scale and summarize results using geometric means. A geometric coefficient of variation describes variability on a proportional scale, rather than expressing spread as an ordinary additive distance around the mean. The registry does not report the detailed transformation or model used for its endpoint summaries.
Cmax is only one aspect of pharmacokinetics. It does not by itself describe the total amount of drug exposure over time or the time at which peak concentration occurs. The registry's primary endpoint is not a clinical efficacy endpoint, and it does not directly indicate whether migraine symptoms changed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the immediate-release reference condition, the reported geometric mean Cmax was 140.0 ng/mL, with a geometric coefficient of variation of 43.0. For the oral-disintegrating tablet without water, the corresponding summary was 123.0 ng/mL, with a geometric coefficient of variation of 42.0. For the oral-disintegrating tablet with water, it was 124.0 ng/mL, with a geometric coefficient of variation of 43.0. The listed arm counts were 46, 46, and 44, respectively. These are descriptive summaries of the posted pharmacokinetic data, not independent-group comparisons.
The registry reports a ratio of geometric least-squares means of 0.875 for the comparison involving immediate-release and oral-disintegrating without water. Its 90% confidence interval is 0.834 to 0.919. For the comparison involving immediate-release and oral-disintegrating with water, the reported ratio is 0.889, with a 90% confidence interval of 0.846 to 0.934. The reported comparison records list the immediate-release condition and each oral-disintegrating condition in that order. The registry does not explain the ratio's numerator and denominator convention in the information, so the ratios should be read with that limitation in mind.
A confidence interval describes the range of values reasonably compatible with the estimate under the analysis and its assumptions. The intervals communicate uncertainty around the reported ratios; they do not show the range of individual participants' concentrations. They also do not establish equivalence on their own. The equivalence margin and the detailed decision rule are not reported in the registry record, so it is not possible to determine from these entries alone whether a formal equivalence criterion was satisfied.
The estimates and intervals are specific to maximum concentration in this healthy-participant study. They do not establish similarity for every pharmacokinetic measure, such as total exposure or time to peak concentration, and they do not address clinical outcomes in people with migraine. The registry lists a primary pharmacokinetic endpoint but does not post secondary outcome results in the information. No p-values are listed for the two reported comparisons.
The descriptive geometric means and the ratios of geometric least-squares means are different kinds of summaries. The first set describes each treatment condition; the ratios summarize pairwise comparisons using the registry's stated least-squares-mean parameter. Details of the fitted model, period effects, sequence effects, and handling of within-participant correlation are not reported. Interpretation should therefore remain anchored to the quantities actually listed rather than assuming an analysis specification that is not described.
9. Statistical Methods Explained
What does the geometric mean describe?
The geometric mean is a way to summarize measurements that vary multiplicatively. General statistical explanation: when measurements are analyzed on a logarithmic scale, the arithmetic mean on that scale corresponds, after transforming back, to a geometric mean on the original scale. This can be useful for pharmacokinetic concentrations because changes are often interpreted proportionally. The registry identifies the primary Cmax summary as a geometric mean, but does not report the exact estimation procedure for the arm summaries.
The geometric coefficient of variation is a measure of relative variability. Unlike a standard deviation on the original measurement scale, it is intended to describe spread in relation to the magnitude of the measurements. The posted values are 43.0 for immediate-release, 42.0 for oral-disintegrating without water, and 43.0 for oral-disintegrating with water. These values do not indicate the range of observed concentrations or how many participants had values near the geometric mean.
What does a ratio of geometric least-squares means mean?
A ratio compares the modeled geometric means for two conditions. General statistical explanation: a ratio is commonly used for pharmacokinetic formulation comparisons because proportional differences are often more meaningful than absolute differences in concentration. A ratio near 1 indicates that the two modeled values are close relative to one another, but the registry does not report the equivalence margin used for this study. The ratio direction also depends on which treatment is placed in the numerator and denominator. Since that convention is not explained in the registry record, the reported values should not be relabeled as a specific test-to-reference or reference-to-test ratio.
The registry lists ratios of geometric least-squares means of 0.875 and 0.889. The first comparison has a 90% confidence interval of 0.834 to 0.919; the second has a 90% confidence interval of 0.846 to 0.934. Least-squares means generally refer to model-based means adjusted for terms in a statistical model. However, the analysis method is not specified in the registry entries, so the adjustment terms and model structure cannot be described.
How should the confidence intervals be read?
General statistical explanation: a confidence interval expresses uncertainty in an estimated quantity under a specified statistical procedure. A narrower interval indicates greater precision than a wider interval on the same scale, while the interval's endpoints mark values compatible with the data and model at the stated confidence level. A 90% confidence interval is not a statement that a particular participant's value has a 90% probability of falling inside the interval. It is also not a range of individual Cmax measurements.
Equivalence analyses typically compare a confidence interval with prespecified acceptable bounds. If the interval falls within those bounds, that can support a formal equivalence conclusion under the chosen procedure. The registry does not state the acceptable bounds, and the reported entries do not include a conclusion field or p-value. The ratio and interval therefore describe the estimates and their uncertainty, but do not by themselves show whether the sponsor's formal equivalence rule was met.
Why does crossover structure matter?
General statistical explanation: repeated observations from the same participant are correlated. A crossover analysis should account for that dependence rather than treating every treatment-period measurement as unrelated. Crossover studies may also be affected by period or sequence effects, and by residual effects of an earlier treatment if a suitable washout is not achieved. The registry identifies a crossover model but does not report treatment sequences, period-specific results, washout details, or the fitted statistical model. The presence and handling of these design features therefore cannot be assessed from the listed results.
A crossover comparison can be efficient because participants can serve as their own reference, reducing the influence of stable differences between people. That benefit depends on appropriate design and analysis. It does not remove uncertainty due to measurement variability, missing observations, period effects, or differences in how participants respond over time. The registry's arm counts cannot be interpreted as separate, non-overlapping groups because the design is crossover.
What does over-dispersion mean in general?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It can make standard errors too small and confidence intervals too narrow if the model does not account for the extra variation. The registry reports geometric coefficients of variation, but does not state that over-dispersion was detected, nor does it describe a diagnostic assessment or adjustment. It would therefore be inappropriate to claim that over-dispersion affected these results.
The analysis method for the reported comparisons is listed as not specified. The registry also does not provide model diagnostics, missing-data procedures, or a detailed analysis plan. These omissions limit independent evaluation of how the ratios and confidence intervals were obtained. The values remain interpretable as the registry's reported estimates, while conclusions about unreported modeling choices should be avoided.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Ratio of Geometric least squares mean 0.875 | 0.834 to 0.919 | not reported |
| not stated | Ratio of Geometric least squares mean 0.889 | 0.846 to 0.934 | not reported |
The registry reports two comparisons as ratios of geometric least-squares means. The immediate-release versus oral-disintegrating-without-water comparison is listed as 0.875, with a 90% confidence interval of 0.834 to 0.919. The immediate-release versus oral-disintegrating-with-water comparison is listed as 0.889, with a 90% confidence interval of 0.846 to 0.934. The method field for these comparisons is not specified.
A simple unadjusted recalculation from arm-level summary statistics is not the same quantity as a model-based ratio of geometric least-squares means. In a crossover study, the paired participant-level structure may also matter to the uncertainty estimate. The registry does not report recalculated comparison estimates or the detailed sponsor model needed to reproduce the listed estimates from the summaries. A numerical comparison between a recalculation and the registry estimates therefore cannot be made from the registry record. The record does not flag a discrepancy between the reported analyses and recalculations.
The sponsor's own analysis is the relevant source for the reported modeled comparisons. The reported ratios and confidence intervals should be interpreted as registry results, without treating the descriptive arm summaries as if they were the same analysis.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and 6 analyses, but reports two comparison estimates for the primary Cmax endpoint in the information. It lists no posted secondary outcome results. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a prespecified approach for controlling error across multiple comparisons. It is therefore not possible to determine how the reported comparisons were situated within the full set of planned analyses.
Multiplicity matters when researchers make several statistical comparisons: the more opportunities there are to identify a result that appears notable by chance, the more important it is to understand whether and how the analysis accounted for those comparisons. This is a general statistical concern, not evidence that the study's reported estimates are incorrect. The registry's count of analyses alone does not establish which analyses were confirmatory, how they were related, or whether adjustment was appropriate.
The primary analysis population is described as participants who received at least one dose of lasmiditan and had evaluable pharmacokinetic data. The registry does not report the number in that population for each comparison, the reasons for any unevaluable data, or how missing concentration measurements were handled. It also does not report whether all randomized participants were included in each analysis or whether any exclusions occurred after randomization.
The record identifies randomization and a crossover design, but does not provide a detailed statistical analysis plan, the model terms, the treatment sequence structure, or procedures for handling incomplete periods. These details could affect the analysis population and the precision of paired comparisons. Since they are not reported in the registry record, conclusions about them cannot be drawn from the posted results.
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 |
|---|---|---|---|
| 100 mg Lasmiditan IR (Reference) | 0 | 47 | 0.0% |
| 100 mg Lasmiditan OD Without Water (Test) | 0 | 46 | 0.0% |
| 100 mg Lasmiditan OD With Water (Test) | 0 | 44 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 100 mg Lasmiditan IR (Reference) | 0 of 47 |
| 100 mg Lasmiditan OD Without Water (Test) | 0 of 46 |
| 100 mg Lasmiditan OD With Water (Test) | 0 of 44 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 100 mg Lasmiditan IR (Reference) | 0 of 47 |
| 100 mg Lasmiditan OD Without Water (Test) | 0 of 46 |
| 100 mg Lasmiditan OD With Water (Test) | 0 of 44 |
The serious adverse event entries report 0 affected participants in each listed treatment condition: immediate-release, oral-disintegrating without water, and oral-disintegrating with water. The registry lists 47 at risk for the immediate-release condition, 46 for oral-disintegrating without water, and 44 for oral-disintegrating with water. The death count is 0 in each condition. Other adverse events are also reported as 0 affected in each listed condition, with the same at-risk counts.
These entries describe what was posted for the listed safety categories; they do not establish that no symptoms or adverse experiences of any kind occurred. The registry's serious adverse event terms list is empty, and the entries do not provide individual event narratives or a broader breakdown of adverse effects. The study summary says adverse effects and tolerability were collected, but the information does not give further detail about those outcomes.
Because this was a crossover study, treatment-condition counts should not be added to infer the number of separate people exposed or to compare the conditions as if they were independent groups. A participant could contribute to more than one condition. The registry entries do not give exposure duration by treatment or a participant-level account of repeated events. The zero counts are therefore descriptive registry reports, not proof that a treatment condition has no safety risks.
13. What the Result Does, and Does Not, Mean
The results describe peak lasmiditan concentrations after three administration conditions in healthy participants. The registry reports geometric mean Cmax values of 140.0 ng/mL for the immediate-release tablet, 123.0 ng/mL for the oral-disintegrating tablet without water, and 124.0 ng/mL for the oral-disintegrating tablet with water. It also reports two geometric least-squares-mean ratios and their 90% confidence intervals. These findings characterize the pharmacokinetic comparisons recorded for this study.
They do not establish whether the formulations are formally equivalent because the registry does not report the equivalence margin or detailed decision rule. They do not describe all pharmacokinetic properties, since the primary result is Cmax and the registry does not post secondary outcome results in the information. Nor do the findings directly measure migraine symptoms, clinical benefit, or how the formulations perform in people experiencing migraine.
The participants were described as healthy, so the results should not be treated as direct evidence about treatment response in a patient population. The registry does not provide demographic details in the record, which also limits assessment of how broadly the participants represent other groups. The study's focus was formulation pharmacokinetics and tolerability, not a comparison of clinical outcomes.
The safety entries report zero serious adverse events, zero other adverse events, and zero deaths in each listed condition. Those are registry counts within the recorded categories, not evidence that an adverse event is impossible or that all potential safety outcomes have been characterized. Arm counts reflect treatment conditions in a crossover design and do not represent mutually exclusive groups.
Overall, the posted data support a narrow reading: they provide descriptive peak-concentration summaries and registry-reported comparison estimates for the listed formulations. Any broader claim about equivalence, clinical effects, or safety requires information beyond these registry entries.
14. Why This Trial Matters Statistically
This study illustrates how formulation comparisons can be framed as pharmacokinetic questions. The oral-disintegrating tablet was compared with an immediate-release tablet, with the test formulation administered either with or without water. Rather than focusing on symptom outcomes, the primary endpoint measures the peak concentration of lasmiditan in blood. That makes the results relevant to understanding systemic exposure across formulations, while keeping the scope distinct from clinical efficacy.
The randomized crossover design is also statistically important. In general, comparing treatment conditions within participants can reduce the influence of stable differences between individuals. At the same time, repeated treatment periods require analysis that respects within-participant dependence and potential period or sequence effects. The registry identifies the crossover design but does not report the details needed to evaluate those analytic choices.
The registry presents both geometric mean summaries and ratios of geometric least-squares means. This provides a useful opportunity to distinguish descriptive treatment-condition summaries from model-based comparisons. The confidence intervals communicate uncertainty, but without reported equivalence bounds they cannot settle whether a formal equivalence rule was satisfied.
The record also demonstrates why registry interpretation depends on what is reported, not just on a point estimate. Missing details include the statistical model, missing-data procedures, treatment sequences, and multiplicity approach. Those omissions do not invalidate the reported results, but they constrain how far an independent reader can assess them. The safety counts likewise require care because a crossover design means treatment-condition entries are not necessarily separate participant groups.
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 does not report the equivalence margin, the detailed statistical model, or the decision rule used to interpret the ratios. Although ratios of geometric least-squares means and 90% confidence intervals are posted, these entries alone do not establish whether a formal equivalence criterion was met. The method field is not specified, and the ratio direction is not explained in the reported record.
The crossover design is identified, but treatment sequences, period details, washout information, and handling of period or sequence effects are not reported. The record also does not describe the within-participant covariance structure or provide diagnostics for the fitted analysis. These omissions limit independent assessment of the precision and assumptions of the comparison estimates.
The primary analysis population requires at least one dose and evaluable pharmacokinetic data, but the registry does not report the population count for each comparison or explain missing and unevaluable observations. The study lists 47 enrolled, while condition-specific summaries list 46, 46, and 44; because it is a crossover trial, those figures do not identify separate, non-overlapping groups or explain exclusions.
The registry does not report demographic characteristics, detailed adverse-event descriptions, or secondary outcome results in the information. It also does not report a multiplicity strategy despite listing 6 analyses. The study was conducted in healthy participants and its primary endpoint is pharmacokinetic, which limits what can be inferred about clinical outcomes in people with migraine. These are limits on interpretation of this record, not evidence that unreported results were unfavorable.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants — NCT04881747.
- Registry record last updated 2023-03-23; status last verified 2021-08.
- Results first posted 2023-03-23.
- 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
NCT04881747 is a completed, randomized, unmasked, phase 1 crossover study sponsored by Eli Lilly and Company. It enrolled 47 healthy participants and compared 100 mg lasmiditan immediate-release tablets with oral-disintegrating tablets administered with or without water.
The primary endpoint was maximum lasmiditan concentration, summarized using geometric means and geometric coefficients of variation. The registry reports two ratios of geometric least-squares means with 90% confidence intervals. It does not report the equivalence margin or detailed analysis method. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in each treatment condition.