A Study of LY3039478 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: LY3039478 original formulation
* Drug: LY3039478 new formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Part A: Placebo<br>Single oral dose of placebo administered in one of three study periods | Drug: Placebo<br>* Administered orally<br>|
| Experimental: Part A: LY3039478 new formulation<br>Escalating single oral dose of LY3039478 administered in two of three study periods | Drug: LY3039478 new formulation<br>* Administered orally<br>|
| Experimental: Part B: LY3039478 original formulation<br>Single oral dose of LY3039478 administered in one of two study periods | Drug: LY3039478 original formulation<br>* Administered orally<br>|
| Experimental: Part B: LY3039478 new formulation<br>Single oral dose of LY3039478 administered in one of two study periods | Drug: LY3039478 new formulation<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time-Matched Difference in QTcF Interval Between LY3039478 (new formulation) Compared To Placebo at the Maximum Concentration (Cmax) of LY3039478 |  | Predose up to 48 hours after administration of study drug in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics; Maximum Concentration (Cmax) of LY3039478 (new formulation) |  | Predose up to 48 hours after administration of study drug in each period | 
| Pharmacokinetics; Area Under the Concentration Versus Time Curve (AUC) of LY3039478 (new formulation) |  | Predose up to 48 hours after administration of study drug in each period | 
| Pharmacokinetics; Maximum Concentration (Cmax) of the 2 Formulations of LY3039478 |  | Predose up to 48 hours after administration of study drug | 
| Pharmacokinetics; Area Under the Concentration Versus Time Curve (AUC) for the 2 formulations of LY3039478 |  | Predose up to 48 hours after administration of study drug |