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Completed

NCT Number: NCT02659865

A Study of LY3039478 in Healthy Participants

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Administered orally

LY3039478 Capsule Formulation (Formulation 3)

Drug

Administered orally

Other names: New Formulation

LY3039478 Drug-in Capsule (Reference, Formulation 1)

Drug

Administered orally

Other names: Original Formulation

LY3039478 Formulated Capsule (Test, Formulation 3)

Drug

Administered orally

Other names: New Formulation

Primary outcomes

  1. Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

    PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched placebo QTcF from their QTcF results after receiving LY3039478. The relationship between plasma concentrations of LY3039478 and ΔQTcF was evaluated using a linear mixed-effects modeling approach. The response variable was ΔQTcF, and concentrations was fitted as a fixed effect with participants as a random effect. The regression slope was presented with the unit in "milliseconds per nanogram per milliliter" abbreviated as "ms/ng/mL".

Secondary outcomes

  1. PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

    PK is Cmax of LY3039478 capsule formulation (formulation 3) in part A.

  2. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

    PK is the area under the concentration versus time curve from zero to infinity (AUC[0-∞]) of LY3039478 capsule formulation (formulation 3) in part A.

  3. PK: Cmax of the 2 Formulations of LY3039478 Part B

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

    PK is the Cmax of the 2 formulations of LY3039478 in part B

  4. PK: AUC(0-∞) of the 2 Formulations of LY3039478 Part B

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

    PK is the AUC(0-∞) of the 2 formulations of LY3039478 in part B.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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