A Study of Lasmiditan in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lasmiditan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04081324

17022 (Registry Identifier)

H8H-MC-LAIC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).

Treatment:

Drug: Placebo

50 milligram (mg) Lasmiditan

Experimental group

Description:

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.

Treatment:

Drug: Lasmiditan

100 mg Lasmiditan

Experimental group

Description:

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.

Treatment:

Drug: Lasmiditan

200 mg Lasmiditan

Experimental group

Description:

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.

Treatment:

Drug: Lasmiditan