Clinical trial NCT04081324: A Study of Lasmiditan in Healthy Chinese Participants
Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan
timeFrame: 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)
measure: PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan
timeFrame: 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)
measure: PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: HuaShan Hospital Affiliated To Fudan University
state: Shanghai
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: