A Study of LY3214996 in Healthy Participants

NCT ID: NCT04033341

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-09-09

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3214996 + [14C]-LY3214996

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

Group Type EXPERIMENTAL

LY3214996

Intervention Type DRUG

Administered orally

[14C]-LY3214996

Intervention Type DRUG

Administered orally

Interventions

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LY3214996

Administered orally

Intervention Type DRUG

[14C]-LY3214996

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Covance Clinical Research Inc

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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I8S-MC-JUAD

Identifier Type: OTHER

Identifier Source: secondary_id

17199

Identifier Type: -

Identifier Source: org_study_id

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