A Study of Lasmiditan in Healthy Japanese and Caucasian Participants
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.
Key facts
- Study ID
- NCT03579940
- Run by
- Eli Lilly and Company
- People needed
- 27
- Starts
- 2018-06-27
- Expected to finish
- 2018-08-09
- Last updated by the study team
- 2019-11-29
Who can join
Age: 20 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
- Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
You may not qualify if…
- Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
- Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
- Have an abnormal supine blood pressure at screening.
- Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.
- Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
- Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening
Where it is running
- Covance — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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