Status:
COMPLETED
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet c...
Eligibility Criteria
Inclusion
- Are overtly healthy as determined by medical evaluation.
- Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).
Exclusion
- Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
- Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
- Have clinically significant abnormalities on ECG, as determined by investigator.
- Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
- Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04881747
Start Date
May 14 2021
End Date
July 24 2021
Last Update
March 23 2023
Active Locations (1)
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1
Covance Dallas
Dallas, Texas, United States, 75247