Status:
COMPLETED
A Study of Multiple Doses of Lasmiditan in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it. When drugs are taken together, one or all of the d...
Eligibility Criteria
Inclusion
- Healthy males or females, as determined by medical history and physical examination
- Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Exclusion
- Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
- Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
- Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds (ms) for men or \>470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
- History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
- History of hypoglycemia
- Known history of glucose-6-phosphate dehydrogenase deficiency
- Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03252015
Start Date
August 15 2017
End Date
January 2 2018
Last Update
January 10 2020
Active Locations (1)
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1
Covance Daytona Beach
Daytona Beach, Florida, United States, 32117