A Study of LY3039478 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3039478 Capsule Formulation (Formulation 3); Drug: LY3039478 Drug-in Capsule (Reference, Formulation 1); Drug: LY3039478 Formulated Capsule (Test, Formulation 3)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Part A: Placebo; Single oral dose of placebo administered in one of three study periods	Drug: Placebo; Administered orally
Experimental: 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	Drug: LY3039478 Capsule Formulation (Formulation 3); Administered orally; Other Names: New Formulation
Experimental: 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	Drug: LY3039478 Drug-in Capsule (Reference, Formulation 1); Administered orally; Other Names: Original Formulation
Experimental: 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	Drug: LY3039478 Formulated Capsule (Test, Formulation 3); Administered orally; Other Names: New Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A	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".	Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A	PK is Cmax of LY3039478 capsule formulation (formulation 3) in part A.	Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A	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.	Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: Cmax of the 2 Formulations of LY3039478 Part B	PK is the Cmax of the 2 formulations of LY3039478 in part B	Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: AUC(0-∞) of the 2 Formulations of LY3039478 Part B	PK is the AUC(0-∞) of the 2 formulations of LY3039478 in part B.	Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 18, 2016
• First Posted (Estimated): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 16263; I6F-MC-JJCE (Other Identifier: Eli Lilly and Company)