Study of LY3039478 in Healthy Participants

January 24, 2017 updated by: Eli Lilly and Company

An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method

The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:

  • How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
  • How long it takes the body to remove the study drug
  • The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Exclusion Criteria:

- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product

• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3039478 - Oral
LY3039478 given once, orally
Drug: LY3039478
Administered orally
Experimental: 13C 15N 2H-LY3039478 - IV
13C 15N 2H-LY3039478 given once, IV
Drug: 3C 15N 2H-LY3039478 IV
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) from Time Zero to the Last Time Point with a Measurable Concentration (AUC[0 tlast]) of LY3039478 and 3C 15N 2H-LY3039478
Time Frame: Predose through 48 hours after administration of study drug
Predose through 48 hours after administration of study drug
Pharmacokinetics: AUC from Zero to Infinity (AUC[0 - inf]) of LY3039478 and 3C 15N 2H-LY3039478
Time Frame: Predose through 48 hours after administration of study drug
Predose through 48 hours after administration of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY3039478
Time Frame: Predose through 48 hours after administration of study drug
Predose through 48 hours after administration of study drug
Pharmacokinetics: Time of Cmax (tmax) of LY3039478
Time Frame: Predose through 48 hours after administration of study drug
Predose through 48 hours after administration of study drug
Pharmacokinetics: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478
Time Frame: Predose through 48 hours after administration of study drug
Predose through 48 hours after administration of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

November 11, 2016

Study Completion (Actual)

November 11, 2016

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 16344
  • I6F-MC-JJCG (Other Identifier: Eli Lilly and Company)
  • 2016-001073-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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