A Study of LY3039478 in Healthy Participants

NCT02659865 | Completed Phase 1 Results

• 2 other identifiers: 16263I6F-MC-JJCE
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

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

  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 Outcomes (4)

• PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) 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

  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

  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

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

Study Arms (4)

Part A: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part A: LY3039478 Capsule Formulation (Formulation 3)

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

Interventions

Placebo DRUG

Administered orally

Part A: Placebo

LY3039478 Capsule Formulation (Formulation 3) DRUG

Administered orally

Also known as: New Formulation

Part A: LY3039478 Capsule Formulation (Formulation 3)

LY3039478 Drug-in Capsule (Reference, Formulation 1) DRUG

Administered orally

Also known as: Original Formulation

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

LY3039478 Formulated Capsule (Test, Formulation 3) DRUG

Administered orally

Also known as: New Formulation

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

crenigacestat; Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Locations

US (1)