A Study of LY3039478 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3039478 new formulation; Drug: LY3039478 original formulation

• Registration Number: NCT02659865
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-18
• Study First Posted: 2016-01-20
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A: Placebo	Placebo	Single oral dose of placebo administered in one of three study periods
Part A: LY3039478 new formulation	LY3039478 new formulation	Escalating single oral dose of LY3039478 administered in two of three study periods
Part B: LY3039478 original formulation	LY3039478 original formulation	Single oral dose of LY3039478 administered in one of two study periods
Part B: LY3039478 new formulation	LY3039478 new formulation	Single oral dose of LY3039478 administered in one of two study periods

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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

Trial Locations

Locations (1)

Covance; 🇺🇸 Daytona Beach, Florida, United States