At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Placebo, LY3039478 Capsule Formulation (Formulation 3), and 2 other interventions for Healthy. Completed, enrolled 29 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Administered orally
Administered orally
Administered orally
Administered orally