A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

Study Overview
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Brief Summary
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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.

Official Title
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Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lasmiditan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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or any components of the formulation of lasmiditan Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan Have an abnormal supine blood pressure at screening.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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasmiditan - Japanese<br>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. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;|
| Placebo Comparator: Placebo - Japanese<br>Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Lasmiditan - Caucasian<br>Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;|
| Placebo Comparator: Placebo - Caucasian<br>Single dose of Placebo administered orally in up to one of three study periods. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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. | Baseline up to Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period | PK: AUC(0-∞) of Lasmiditan in Each Period was evaluated. | 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: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period | PK: Cmax of Lasmiditan in Each Period was evaluated. | 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 |