A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants

NCT ID: NCT06052462

Last Updated: 2024-01-05

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2023-11-04

Brief Summary

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The main purpose of this study is to evaluate how much of the study drug (LY3556050), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[14C]-LY3556050

Single dose of \[¹⁴C\]-LY3556050 administered orally

Group Type EXPERIMENTAL

[14C]-LY3556050

Intervention Type DRUG

Administered orally

Interventions

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[14C]-LY3556050

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive
* Males who agree to use highly effective or effective methods of contraception

Exclusion Criteria

* Have known allergies to LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy
* Have clinically significant abnormal BP and/or pulse rate as determined by the investigator
* Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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LabCorp CRU, Inc.

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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J2P-MC-LXBC

Identifier Type: OTHER

Identifier Source: secondary_id

18347

Identifier Type: -

Identifier Source: org_study_id

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