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

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LY3039478

Study type

Interventional

Funder types

Industry

Identifiers

NCT02917733

I6F-MC-JJCF (Other Identifier)

16343

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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