A Study of LY3039478 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part A: LY3039478 Capsule Formulation (Formulation 3)

Escalating single oral dose of 25 milligram (mg), 50 mg, and 75 mg capsule formulation (formulation 3) LY3039478 administered in two of three study periods

Group Type EXPERIMENTAL

LY3039478 Capsule Formulation (Formulation 3)

Intervention Type DRUG

Administered orally

Part B: LY3039478 Drug-In Capsule (Reference, Formulation 1)

Single oral 50 mg dose of drug-in capsule (reference, formulation 1) LY3039478 administered in one of two study periods

Group Type EXPERIMENTAL

LY3039478 Drug-in Capsule (Reference, Formulation 1)

Intervention Type DRUG

Administered orally

Part B: LY3039478 Formulated Capsule (Test, Formulation 3)

Single oral 50 mg dose of formulated capsule (test, formulation 3) LY3039478 administered in one of two study periods

Group Type EXPERIMENTAL

LY3039478 Formulated Capsule (Test, Formulation 3)

Intervention Type DRUG

Administered orally

Interventions

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Placebo

Administered orally

Intervention Type DRUG

LY3039478 Capsule Formulation (Formulation 3)

Administered orally

Intervention Type DRUG

LY3039478 Drug-in Capsule (Reference, Formulation 1)

Administered orally

Intervention Type DRUG

LY3039478 Formulated Capsule (Test, Formulation 3)

Administered orally

Intervention Type DRUG

Other Intervention Names

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New Formulation Original Formulation New Formulation

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 prior to enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes