A Study of LY3214996 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3214996; Drug: [14C]-LY3214996

• Registration Number: NCT04033341
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Study Start: 2019-08-01
• Primary Completion: 2019-09-09
• Study Completion: 2019-09-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-26
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3214996 + [14C]-LY3214996	LY3214996	A single dose of LY3214996 and \[14C\]-LY3214996 administered orally.
LY3214996 + [14C]-LY3214996	[14C]-LY3214996	A single dose of LY3214996 and \[14C\]-LY3214996 administered orally.

Primary Outcome Measures

Name	Time	Method
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered	Baseline through Day 8 after administration of study drug	Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered	Baseline through Day 8 after administration of study drug	Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996	Predose through Day 8 after administration of study drug	PK: Cmax of LY3214996
PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996	Predose through Day 8 after administration of study drug	PK: AUC(0-∞) of LY3214996
Total Number of Metabolites of LY3214996	Baseline through 48 hours after administration of study drug	Total Number of Metabolites of LY3214996

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Madison, Wisconsin, United States