Phase 1
Completed N=29
A Study of LY3039478 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02659865 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A — -0.001 ms/ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A |
-0.001 | — |
| SECONDARY PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A |
158; 296; 461 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A |
711; 1400; 2090 | — |
| SECONDARY PK: Cmax of the 2 Formulations of LY3039478 Part B |
322; 384 | — |
| SECONDARY PK: AUC(0-∞) of the 2 Formulations of LY3039478 Part B |
1340; 1750 | — |
Eligibility Criteria
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 prior to enrollment
Data sourced from ClinicalTrials.gov (NCT02659865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.