A Study of Lasmiditan in Healthy Chinese Participants

Study Overview
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Brief Summary
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This is a study of lasmiditan in healthy Chinese participants. The purposes are: To evaluate the safety of lasmiditan To learn more about how the body processes lasmiditan The study will last up to 50 days for each participant.

Official Title
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Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Chinese 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 Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin) males or females, as determined by medical history and physical examination Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive Are able and willing to give signed informed consent Exclusion Criteria: Have known allergies to lasmiditan, related compounds or any components of the formulation Have an abnormal blood pressure and/or pulse rate as determined clinically significant by the investigator Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression) Have a history of central nervous system (CNS) conditions such as strokes, transient ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study Regularly use known drugs of abuse and/or show positive findings on drug screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). | Drug: Placebo<br>* Administered orally<br>|
| Experimental: 50 milligram (mg) Lasmiditan<br>Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;|
| Experimental: 100 mg Lasmiditan<br>Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;|
| Experimental: 200 mg Lasmiditan<br>Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1). | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose | 
| PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10). | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) | 
| PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10). | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) | 
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10). | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) |