A Study of LY3039478 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3039478 original formulation; Drug: LY3039478 new formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02659865

16263

I6F-MC-JJCE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 4 patient groups, including a placebo group

Part A: Placebo

Placebo Comparator group

Description:

Single oral dose of placebo administered in one of three study periods

Treatment:

Drug: Placebo

Part A: LY3039478 new formulation

Experimental group

Description:

Escalating single oral dose of LY3039478 administered in two of three study periods

Treatment:

Drug: LY3039478 new formulation

Part B: LY3039478 original formulation

Experimental group

Description:

Single oral dose of LY3039478 administered in one of two study periods

Treatment:

Drug: LY3039478 original formulation

Part B: LY3039478 new formulation

Experimental group

Description:

Single oral dose of LY3039478 administered in one of two study periods

Treatment:

Drug: LY3039478 new formulation