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A Study of LY3214996 in Healthy Participants

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Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3214996
Drug: [14C]-LY3214996

Study type

Interventional

Funder types

Industry

Identifiers

NCT04033341
17199
I8S-MC-JUAD (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.

Enrollment

6 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Overtly health males
  • Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion criteria

  • Females
  • Male participants sexually active with a pregnant partner
  • Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
  • Have participated in a radiolabeled drug study within the previous 4 months
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Have a history of Gilbert's syndrome
  • Have history or presence of psychiatric disorders
  • Show evidence of human immunodeficiency virus (HIV) infection
  • Show evidence of hepatitis C
  • Show evidence of hepatitis B

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

LY3214996 + [14C]-LY3214996
Experimental group
Description:
A single dose of LY3214996 and \[14C\]-LY3214996 administered orally.
Treatment:
Drug: [14C]-LY3214996
Drug: LY3214996

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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