A Study of LY3214996 in Healthy Participants

NCT04033341 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17199I8S-MC-JUAD
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (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

  Predose through Day 8 after administration of study drug

• Total Number of Metabolites of LY3214996

  Baseline through 48 hours after administration of study drug

Study Arms (1)

LY3214996 + [14C]-LY3214996

EXPERIMENTAL

A single dose of LY3214996 and \[14C\]-LY3214996 administered orally.

Drug: LY3214996; Drug: [14C]-LY3214996

Interventions

LY3214996 DRUG

Administered orally

LY3214996 + [14C]-LY3214996

[14C]-LY3214996 DRUG

Administered orally

LY3214996 + [14C]-LY3214996

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

LY3214996

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: August 1, 2019
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)