A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02917733

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3039478	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Disposition of [¹⁴C₂]-Labeled LY3039478 Following Oral Administration in Healthy Subjects

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiolabelled LY3039478 Single dose of radiolabelled LY3039478 administered orally.	Drug: LY3039478 Administered orally

Arm

Intervention/Treatment

Experimental: Radiolabelled LY3039478

Single dose of radiolabelled LY3039478 administered orally.

Drug: LY3039478

Administered orally

Outcome Measures

Primary Outcome Measures

Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to 168 hours after administration of study drug]

Secondary Outcome Measures

Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3039478 [Predose through 168 hours postdose]
Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity [Predose through 168 hours postdose]
Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478 [Predose through 168 hours postdose]
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity [Predose through 168 hours postdose]
Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces [Predose through 168 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Have a body mass index (BMI) of 18 to 32 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
Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
Have participated in a [¹⁴C] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe: less than 5000 millirem (mrem)/year whole body annual exposure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Inc	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT02917733

Other Study ID Numbers:

16343
I6F-MC-JJCF

First Posted:

Sep 28, 2016

Last Update Posted:

Jan 10, 2017

Last Verified:

Jan 1, 2017

Study Results

No Results Posted as of Jan 10, 2017