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A Study of LY3039478 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659865
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: LY3039478 original formulation Drug: LY3039478 new formulation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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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 new formulation
Escalating single oral dose of LY3039478 administered in two of three study periods
 Drug: LY3039478 new formulation
Administered orally
Experimental: Part B: LY3039478 original formulation
Single oral dose of LY3039478 administered in one of two study periods
 Drug: LY3039478 original formulation
Administered orally
Experimental: Part B: LY3039478 new formulation
Single oral dose of LY3039478 administered in one of two study periods
 Drug: LY3039478 new formulation
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Mean Time-Matched Difference in QTcF Interval Between LY3039478 (new formulation) Compared To Placebo at the Maximum Concentration (Cmax) of LY3039478 [ Time Frame: Predose up to 48 hours after administration of study drug in each period ]

Secondary Outcome Measures :
  1. Pharmacokinetics; Maximum Concentration (Cmax) of LY3039478 (new formulation) [ Time Frame: Predose up to 48 hours after administration of study drug in each period ]
  2. Pharmacokinetics; Area Under the Concentration Versus Time Curve (AUC) of LY3039478 (new formulation) [ Time Frame: Predose up to 48 hours after administration of study drug in each period ]
  3. Pharmacokinetics; Maximum Concentration (Cmax) of the 2 Formulations of LY3039478 [ Time Frame: Predose up to 48 hours after administration of study drug ]
  4. Pharmacokinetics; Area Under the Concentration Versus Time Curve (AUC) for the 2 formulations of LY3039478 [ Time Frame: Predose up to 48 hours after administration of study drug ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659865


Locations
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United States, Florida
Covance
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02659865    
Other Study ID Numbers: 16263
I6F-MC-JJCE ( Other Identifier: Eli Lilly and Company )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016