A Study of LY3039478 in Healthy Participants

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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