A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

Phase 1

Completed

Brief Summary: The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.

Recruitment & Eligibility

Inclusion Criteria

Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria

Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
Have an abnormal supine blood pressure at screening.
Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.
Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening

Arm && Interventions

Group	Intervention	Description
Placebo - Japanese	Placebo	Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods.
Placebo - Caucasian	Placebo	Single dose of Placebo administered orally in up to one of three study periods.
Lasmiditan - Japanese	Lasmiditan	Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods.
Lasmiditan - Caucasian	Lasmiditan	Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Day 20	The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period	Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose	PK: AUC(0-∞) of Lasmiditan in Each Period was evaluated.
PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period	Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose	PK: Cmax of Lasmiditan in Each Period was evaluated.