A Study of LY3039478 in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 7/13/2016 |
Start Date: | January 2016 |
End Date: | June 2016 |
A Single Ascending Dose Study for the Evaluation of the Effects of LY3039478 on the QT/Corrected QT Interval in Healthy Subjects and Pilot Relative Bioavailability
The main purpose of this study is to investigate the safety of the study drug known as
LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part
A has three periods. Either LY3039478 or placebo will be given once by mouth in each period.
Part B has two periods. Participants will receive both formulations of LY3039478, by mouth,
over the course of the study. Both parts of the study will also explore how much LY3039478
gets into the bloodstream and how long it takes the body to get rid of it. Information about
any side effects will also be collected. Participants may only enroll in one part. The study
will last at least 33 days, not including screening. Screening must be performed up to 30
days before enrollment.
Part B was added by protocol amendment approved in April, 2016.
LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part
A has three periods. Either LY3039478 or placebo will be given once by mouth in each period.
Part B has two periods. Participants will receive both formulations of LY3039478, by mouth,
over the course of the study. Both parts of the study will also explore how much LY3039478
gets into the bloodstream and how long it takes the body to get rid of it. Information about
any side effects will also be collected. Participants may only enroll in one part. The study
will last at least 33 days, not including screening. Screening must be performed up to 30
days before enrollment.
Part B was added by protocol amendment approved in April, 2016.
Inclusion Criteria:
- Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)
Exclusion Criteria:
- Known allergies to LY3039478, related compounds or any components of the formulation
- Have previously received LY3039478
- Smokers or who have stopped smoking less than 3 months ago
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