A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants

NCT ID: NCT06342596

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2024-05-01

Brief Summary

The main purpose of this study is to evaluate how much of the study drug (LY3473329), 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 when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C]-LY3473329 (Part 1)

Single dose of \[¹⁴C\]-LY3473329 administered orally

Group Type: EXPERIMENTAL

[14C]-LY3473329

Intervention Type: DRUG

Administered orally

LY3473329 + [14C]-LY3473329 (Part 2)

Single dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV)

Group Type: EXPERIMENTAL

[14C]-LY3473329

Intervention Type: DRUG

Administered IV

LY3473329

Intervention Type: DRUG

Administered orally

Interventions

[14C]-LY3473329

Administered orally

Intervention Type: DRUG

[14C]-LY3473329

Administered IV

Intervention Type: DRUG

LY3473329

Administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male participants who are overtly healthy as determined by medical evaluation
• Have a body mass index of 18.0 to 35.0 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 LY3473329, related compounds, or any components of the formulation, or history of significant atopy
• Have a history of constipation or have had acute constipation within 3 weeks prior to check-in
• Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in. Any previous radiolabeled study intervention must have been received more than 12 months prior to check-in
• Have used or plan to use over-the-counter or prescription medication within 14 days prior to dosing, or any medications or products known to alter drug absorption, metabolism, or elimination processes
• Have participated, within the last 3 months, in a clinical study involving an investigational product

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Fortrea Clinical Research Unit

Holbeck, Leeds, United Kingdom

Countries

United Kingdom

Other Identifiers

J2O-MC-EKBD

Identifier Type: OTHER

Identifier Source: secondary_id

18597

Identifier Type: -

Identifier Source: org_study_id