A Study of Lasmiditan in Healthy Chinese Participants

NCT04081324 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17022H8H-MC-LAIC
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

50 milligram (mg) Lasmiditan

EXPERIMENTAL

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

100 mg Lasmiditan

EXPERIMENTAL

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

200 mg Lasmiditan

EXPERIMENTAL

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

Interventions

Lasmiditan DRUG

Administered orally

Also known as: LY573144

100 mg Lasmiditan; 200 mg Lasmiditan; 50 milligram (mg) Lasmiditan

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

HuaShan Hospital Affiliated To Fudan University

Shanghai, Shanghai Municipality, 20040, China

Location

MeSH Terms

Interventions

lasmiditan

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: November 13, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: July 1, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)