A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lasmiditan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03579940

H8H-JE-LAIE (Other Identifier)

17010

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 4 patient groups, including a placebo group

Lasmiditan - Japanese

Experimental group

Description:

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.

Treatment:

Drug: Lasmiditan

Placebo - Japanese

Placebo Comparator group

Description:

Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods.

Treatment:

Drug: Placebo

Lasmiditan - Caucasian

Experimental group

Description:

Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods.

Treatment:

Drug: Lasmiditan

Placebo - Caucasian

Placebo Comparator group

Description:

Single dose of Placebo administered orally in up to one of three study periods.

Treatment:

Drug: Placebo