Phase 1
Completed N=36
A Study of Lasmiditan in Healthy Chinese Participants
Healthy
Source: ClinicalTrials.gov NCT04081324 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan — 385; 829; 1990 nanogram*hour per milliliter (ng*h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan |
385; 829; 1990 | — |
| PRIMARY PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan |
378; 809; 1950; 429; 898; 2140 | — |
| PRIMARY PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan |
69.6; 154; 359; 78.8; 187; 394 | — |
| PRIMARY PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan |
1.50; 1.50; 1.50; 1.75; 1.50; 1.50 | — |
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
Data sourced from ClinicalTrials.gov (NCT04081324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.