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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3473329; Drug: [14C]-LY3473329

Study type: Interventional

Funder types: Industry

Identifiers

NCT06342596

18597

J2O-MC-EKBD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

[14C]-LY3473329 (Part 1)

Experimental group

Description:

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

Treatment:

Drug: [14C]-LY3473329

Drug: [14C]-LY3473329

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

Experimental group

Description:

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

Treatment:

Drug: [14C]-LY3473329

Drug: [14C]-LY3473329

Drug: LY3473329