Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function (NCT03009162), a non-randomized phase 1 study. The primary outcome is Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax).

2. Clinical Question

3. Trial Design

This was a Phase I, multicenter, open-label, non-randomized, parallel-group, adaptive, single-dose pharmacokinetic study. The registry record lists an enrollment of 16 and a completed status. The study began on 2017-04-01, and the primary completion date was 2017-06-02. Those record dates describe the trial timeline; they do not supply pharmacokinetic results.

The brief description planned enrollment of up to 32 participants. It described an initial stage of approximately 16 participants: 8 with severe renal impairment and 8 healthy participants with normal renal function. The normal-function group was defined by estimated glomerular filtration rate (eGFR) at least 90 mL/min/1.73m², while severe impairment was defined as eGFR less than 30 mL/min/1.73m². The plan allowed for groups with moderate and mild impairment to be enrolled if safety and pharmacokinetic results in the severe-impairment group showed a substantial change in exposure. Whether those additional groups were enrolled is not reported in the registry record.

Participants received one 200 mg oral dose of lasmiditan. The registry lists the arms as healthy participants and renal-impaired participants, with the same single-dose description for each. Because allocation was non-randomized and renal function defined the groups, group differences may reflect characteristics associated with renal status as well as any pharmacokinetic relationship. The record does not report detailed matching variables, the final group composition, or the operational rules used to adapt enrollment. It also does not report a statistical analysis plan or numerical results for the primary pharmacokinetic outcome.

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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) 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 who received at least one dose of study drug.

6. Primary Endpoint

The registry lists the primary outcome as Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax), measured over Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose.

The primary endpoint was the maximum observed plasma concentration of lasmiditan, abbreviated Cmax, measured in nanograms per milliliter. It represents the highest concentration recorded in the sampled plasma measurements after dosing. The planned sampling schedule extended from predose through 36 hours postdose, with multiple postdose collection times. Cmax is a pharmacokinetic measure: it describes drug concentration in blood, rather than a clinical symptom or treatment response.

General statistical context: a maximum concentration can help characterize the peak of a drug’s measured exposure after a dose. Comparing that measure across renal-function groups can describe whether the observed concentration profile differs in those groups. Cmax depends on the sampling schedule, because the observed maximum is the highest measured value among collection times, not necessarily a continuously observed peak.

The registry specified that Cmax would be summarized as a geometric mean with geometric coefficient of variation as its dispersion measure. The endpoint population was defined as enrolled participants who received at least one dose and had evaluable pharmacokinetic data. The record does not report the group-specific geometric means, coefficients of variation, confidence intervals, or a statistical comparison. Consequently, the endpoint definition and planned measurement can be described, but the posted record does not establish the observed Cmax pattern or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study was designed to describe pharmacokinetics after one oral dose of lasmiditan in groups defined by renal function. Its primary measure was maximum observed plasma concentration (Cmax), summarized using a geometric mean and geometric coefficient of variation. The registry record lists 8 outcome measures but no analyses. It does not report a statistical analysis plan or numerical primary-endpoint results.

What does a geometric mean describe?

General statistical context: a geometric mean summarizes values on a multiplicative scale. It is often used for concentration data when values are positive and variation is better understood in proportional rather than additive terms. It is not the same summary as an arithmetic mean. The registry names a geometric mean for Cmax but does not provide its value for either group.

General statistical context: the geometric coefficient of variation describes relative spread around a geometric mean. It can help readers understand how variable concentration measurements are within a group. It is not a confidence interval, and it does not by itself quantify the precision of a comparison between groups. No geometric coefficients of variation are reported in the registry record.

How should the endpoint’s sampling be understood?

General statistical context: Cmax is the largest observed concentration among the scheduled measurements. The registry lists sampling from predose through 36 hours postdose, including multiple postdose time points. With discrete sampling, the observed maximum is tied to those collection times. The record does not report the actual concentration-time data, individual maxima, or whether any planned measurements were missing.

The record defines the primary endpoint population as participants who received at least one dose and had evaluable pharmacokinetic data. This is a stated eligibility rule for the endpoint analysis, not a report of how many participants met it. The number with evaluable pharmacokinetic data is not reported in the registry record.

What does the non-randomized design imply?

General statistical context: random allocation can help balance participant characteristics between groups, on average. In this study, allocation was non-randomized, and renal function determined group membership. The normal-function group is therefore a reference group, not a randomized treatment control. Differences in Cmax between groups, if available, would be descriptive of the groups studied and would not automatically isolate renal function from other group differences.

The registry describes the study as parallel-group and open-label. Parallel-group means participants were assigned to a group rather than described as crossing through every renal-function category. Open-label means the study was not masked. The record does not state what role, if any, knowledge of group status had in pharmacokinetic measurement or analysis. It also does not report a matching procedure beyond its description of matched participants in the initial plan.

What does the adaptive description establish?

The brief description says that moderate- and mild-impairment groups could be enrolled if safety and pharmacokinetic results in the severe-impairment group showed a substantial change in exposure. General statistical context: an adaptive design can use accumulating information to guide later enrollment or study conduct. Its interpretation depends on the specific decision rules, timing, and analysis methods. Those details are not reported in the registry record. The description of a possible adaptation does not establish that additional groups were enrolled or that the decision condition occurred.

How should planning calculations be read?

The record describes sample-size illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the target effect is a stated fraction of the observed effect. For non-time-to-event outcomes, those illustrations are expressed as participants per arm for 80% power or 90% power; time-to-event illustrations, if present, use a total event count. These are planning illustrations, not observed power and not the trial’s stated design justification. The record does not report the numerical observed effect or the resulting planning values in the registry record for this interpretation. The trial’s own sample-size justification is not reported in the registry record.

General statistical context: a confidence interval, when reported, describes uncertainty around an estimate under the assumptions of its analysis. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. The registry record does not report confidence intervals for Cmax, so the precision of a group comparison cannot be assessed from this record.

General statistical context: over-dispersion means that observed variation exceeds what a chosen statistical model expects. Accounting for it can matter when the model’s assumptions otherwise understate variability and uncertainty. The record does not identify a model for Cmax or report over-dispersion diagnostics, so there is no basis to say whether over-dispersion was assessed or relevant to the sponsor’s analysis.

Are sponsor analyses and recalculations available?

The record lists no analyses, and no numerical primary-endpoint summary statistics are reported. A simple recalculation from posted summary statistics is therefore not available from this record. The record does not report a sponsor analysis to compare with a recalculated estimate. In general, where a sponsor’s own analysis and an unadjusted recalculation differ, the sponsor’s own analysis takes precedence; that situation cannot be evaluated from the information, and this explanation does not produce a new estimate.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures, but it does not report analyses. Cmax is identified as the primary outcome; adverse events are listed as a secondary outcome. The record does not provide a complete outcome-by-outcome results set or a multiplicity-adjustment method. It is therefore not possible to determine from the registry whether or how the possibility of multiple statistical tests was addressed. The statistical plan, including any planned hierarchy or adjustment, is not reported in the registry record.

The Cmax endpoint population is described as enrolled participants who received at least one dose and had evaluable pharmacokinetic data. The record does not report how many participants were included in that population, whether any participants lacked evaluable data, or how missing measurements were handled. Imputation methods, exclusions from analysis, and sensitivity analyses are not reported in the registry record.

The safety counts are reported for 8 participants in each listed group, with adverse-event counts described in the safety section. The record does not explain how participants with incomplete safety follow-up were handled or provide follow-up duration. The primary completion date is reported, but this does not supply missing-data procedures or analysis-population details.

The adaptive description makes enrollment of additional renal-function groups conditional on safety and pharmacokinetic information. The decision rules and their statistical implications are not reported. The record also does not specify whether any interim analyses were planned or conducted. None should be inferred from the adaptive wording alone.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 8 participants at risk for serious adverse events in each group: healthy participants and renal-impaired participants. It reports 0 serious adverse events in each group and 0 deaths in each group. The record lists 6 participants with other adverse events in each group. These are counts, not a comparison adjusted for participant characteristics or exposure time.

The registry provides no serious adverse-event terms. It also does not identify the other adverse events, their seriousness classifications beyond the listed categories, severity, timing, duration, or relationship to lasmiditan. The counts do not show whether events were concentrated in any particular type, and they do not describe the experience of participants beyond the events recorded.

Because both groups received a single 200 mg oral dose and were defined by renal function rather than randomized assignment, the counts should be read descriptively. They do not establish a causal difference in safety between groups. The registry record does not report a detailed safety analysis or a comparison test. The absence of a reported serious adverse event in these groups is a statement about the posted counts, not a guarantee about other settings or participants.

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

The record describes a small Phase I pharmacokinetic study of single-dose lasmiditan across normal and impaired renal-function groups. It identifies Cmax as the primary endpoint and specifies how that measure was to be summarized. It also reports adverse-event counts for the listed groups. These registry entries establish what the study set out to examine and what safety counts were posted, but they do not provide the numerical pharmacokinetic findings.

Without group-specific Cmax estimates, dispersion measures, or an analysis, the direction, size, and precision of any concentration difference are unknown from the registry record. The result cannot be characterized as showing higher, lower, or similar concentrations across renal-function groups. The adaptive plan’s mention of possible later enrollment is not a substitute for reported results, and the final enrollment by renal-function category is not reported.

The non-randomized design also limits what a group comparison could establish. Renal status defined the groups, and the registry warns that the arms are not a like-for-like control comparison. Even if numerical differences were available, interpretation would depend on group composition and analysis details that are not reported in this record.

The safety figures show the posted counts: no serious adverse events or deaths were reported in either listed group, and other adverse events were recorded in both. The record does not give the event terms or enough detail to assess their nature or relation to treatment. These counts should not be converted into a broader claim about safety.

This is a pharmacokinetic study, not a trial designed in the registry record to establish a clinical benefit for migraine. The record does not report a migraine symptom outcome or a treatment comparison for clinical effectiveness. Accordingly, it supports neither a conclusion that lasmiditan does nor does not work for a clinical outcome. It describes the design and limited posted results, while the primary pharmacokinetic result remains unavailable in the registry record.

13. Why This Trial Matters Statistically

Renal function can be an important grouping variable in pharmacokinetic research because studies may examine whether measured drug concentrations differ across levels of renal impairment. This trial’s stated purpose was to characterize lasmiditan pharmacokinetics after a single oral dose in participants with normal and impaired renal function. Its primary endpoint, Cmax, focuses on the maximum measured plasma concentration rather than a clinical outcome.

Statistically, the design illustrates why a reference group should not automatically be treated as a randomized control. Participants were grouped by renal function, and allocation was non-randomized. A comparison can describe observed concentration patterns, but group differences may also reflect other differences between participants. The registry’s explicit warning against treating the arms as like-for-like controls is therefore important when interpreting any comparative claim.

The adaptive plan is also relevant to study interpretation. The brief description allows further renal-function groups depending on safety and pharmacokinetic information from the severe-impairment group. That approach can shape the populations eventually studied, but the record does not report whether additional groups were enrolled or the decision rules in detail. The stated enrollment and adaptive plan should be distinguished from the final composition of analyzed groups.

Finally, the record demonstrates the difference between a clearly defined endpoint and a reported endpoint result. It names Cmax, the measurement unit, the summary measure, and the intended population, yet gives no numerical Cmax findings or analyses. Without those estimates and their uncertainty, readers cannot assess the size or precision of the pharmacokinetic comparison. The study is statistically informative as a design description, but the posted record does not support a quantitative conclusion about its primary question.

14. 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 main limitation for interpreting this registry record is that it does not report numerical results for the primary endpoint. Group-specific Cmax estimates, geometric coefficients of variation, confidence intervals, and a comparison analysis are absent. The record therefore cannot quantify the pharmacokinetic pattern or its precision.

The study was non-randomized, open-label, and organized by renal-function group. The registry specifically cautions that its arms are not a like-for-like control comparison. It does not report detailed group characteristics, matching variables, or adjusted analyses that might help readers understand the comparability of groups.

The brief description gives a conditional plan for adding moderate- and mild-impairment groups, but the final enrollment by renal-function category is not reported. The record lists 16 enrolled participants overall, while describing an adaptive plan of up to 32. The final number with evaluable pharmacokinetic data is also not reported. Thus, the stated enrollment does not establish the analysis population for Cmax.

The record provides limited safety detail. It reports counts for serious and other adverse events and deaths, but does not report event terms for the other adverse events, severity, timing, duration, attribution, or follow-up duration. No serious adverse-event terms are listed.

Further limitations include the absence of a reported statistical analysis plan, missing-data methods, multiplicity procedures, and details of any adaptive decision rules. The record does not report whether interim analyses were planned or conducted. These omissions prevent assessment of how the stated design was implemented and how results would have been analyzed.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function — NCT03009162.
• Registry record last updated 2019-12-02; status last verified 2018-03.
• Results first posted 2019-12-02.
• 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.

18. Record Summary

NCT03009162 is a completed Phase I, multicenter, open-label, non-randomized, parallel-group, adaptive, single-dose pharmacokinetic study of oral lasmiditan in participants with normal and impaired renal function. The registry lists enrollment of 16, a start date of 2017-04-01, and a primary completion date of 2017-06-02. Participants in the listed groups received a single 200 mg oral tablet.

The primary endpoint was maximum observed plasma concentration (Cmax), summarized as a geometric mean with geometric coefficient of variation. The registry record does not report numerical Cmax results or analyses. Safety counts show 0 serious adverse events and 0 deaths in each listed group, with 6 participants having other adverse events in each group. Event details are not reported. The design is non-randomized, and the registry cautions that the arms are not a like-for-like control comparison.