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

Eli Lilly and Company16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]-LY3473329DRUG

Administered orally

[14C]-LY3473329DRUG

Administered IV

LY3473329DRUG

Administered orally

Eligibility

Sex: MALEMin age: 35 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fortrea Clinical Research Unit

Holbeck, Leeds, United Kingdom

Outcomes

Primary Outcomes

Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame: Day 1 up to Day 29 post dose

Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame: Day 1 up to Day 29 post dose

Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329

Part 2: PK: F of LY3473329

Time frame: Day 1 up to Day 9 post dose

Secondary Outcomes

Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329

Part 1: PK: AUC(0-tlast) of LY3473329

Time frame: Day 1 up to Day 29 post dose

Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity

Part 1: PK: AUC(0-tlast) of Total Radioactivity

Time frame: Day 1 up to Day 29 post dose

Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329

Part 1: PK: AUC(0-∞) of LY3473329

Time frame: Day 1 up to Day 29 post dose

Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity

Data from ClinicalTrials.gov

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