A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants

Summary

The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.

Timeline

Start

2021-05-14

Primary completion

2021-07-24

Completion

2021-07-24

Outcome

Met primary endpoint

registry analysis (equivalence test); 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD Without Water (Test); Ratio of Geometric least squares mean 0.875 (90% CI 0.834 to 0.919) NCT04881747 ↗

registry analysis (equivalence test); 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD With Water (Test); Ratio of Geometric least squares mean 0.889 (90% CI 0.846 to 0.934) NCT04881747 ↗

registry analysis (equivalence test); 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD Without Water (Test); Ratio of Geometric least squares mean 0.944 (90% CI 0.914 to 0.976) NCT04881747 ↗

registry analysis (equivalence test); 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD With Water (Test); Ratio of Geometric least squares mean 0.946 (90% CI 0.914 to 0.978) NCT04881747 ↗

registry analysis (equivalence test); 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD Without Water (Test); Ratio of Geometric least squares mean 0.941 (90% CI 0.910 to 0.972) NCT04881747 ↗

registry analysis (equivalence test); 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD With Water (Test); Ratio of Geometric least squares mean 0.944 (90% CI 0.913 to 0.977) NCT04881747 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lasmiditan	Small molecule	100 mg	Oral

Indications

No indication recorded.