A Study of LY3214996 in Healthy Participants

Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3214996; Drug: [14C]-LY3214996

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3214996 + [14C]-LY3214996; A single dose of LY3214996 and [14C]-LY3214996 administered orally.	Drug: LY3214996; Administered orally; Drug: [14C]-LY3214996; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered	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
Fecal 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 26, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17199; I8S-MC-JUAD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No