A Study of Lasmiditan in Healthy Chinese Participants

Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Chinese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Lasmiditan

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20040
      • Huashan Hospital affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).	Drug: Placebo; Administered orally
Experimental: 50 milligram (mg) Lasmiditan; 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; Administered orally; Other Names: LY573144
Experimental: 100 mg Lasmiditan; 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; Administered orally; Other Names: LY573144
Experimental: 200 mg Lasmiditan; 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; Administered orally; Other Names: LY573144

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: 17022 (Registry Identifier: National Institute for Health Research Portfolio ID); H8H-MC-LAIC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes