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

A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3473329; Drug: [14C]-LY3473329; Drug: [14C]-LY3473329

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds
    • Holbeck, Leeds, United Kingdom, LS11 9EH
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-LY3473329 (Part 1); Single dose of [¹⁴C]-LY3473329 administered orally	Drug: [14C]-LY3473329; Administered orally; Drug: [14C]-LY3473329; Administered IV
Experimental: LY3473329 + [14C]-LY3473329 (Part 2); Single dose of LY3473329 administered orally followed by a single dose of [¹⁴C]-LY3473329 administered intravenously (IV)	Drug: LY3473329; Administered orally; Drug: [14C]-LY3473329; Administered orally; Drug: [14C]-LY3473329; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	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	Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Day 1 up to Day 29 post dose
Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329	Part 2: PK: F of LY3473329	Day 1 up to Day 9 post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Part 1: PK: AUC(0-∞) of Total Radioactivity	Day 1 up to Day 29 post dose
Part 1: PK: Maximum Concentration (Cmax) of LY3473329	Part 1: PK: Cmax of LY3473329	Day 1 up to Day 29 post dose
Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity	Part 1: PK: Cmax of Total Radioactivity	Day 1 up to Day 29 post dose
Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Day 1 up to Day 29 post dose
Part 1: Total Number of Metabolites of LY3473329	Part 1: Total Number of Metabolites of LY3473329	Day 1 up to Day 29 post dose
Part 2: PK: AUC (0-∞) of LY3473329	Part 2: PK: AUC (0-∞) of LY3473329	Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of [14C]-LY3473329	Part 2: PK: AUC (0-∞) of [14C]-LY3473329	Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of Total Radioactivity	Part 2: PK: AUC (0-∞) of Total Radioactivity	Day 1 up to Day 9 post dose
Part 2: PK: Cmax of LY3473329	Part 2: PK: Cmax of LY3473329	Day 1 up to Day 9 post dose
Part 2: PK: Cmax of [14C]-LY3473329	Part 2: PK: Cmax of [14C]-LY3473329	Day 1 up to Day 9 post dose
Part 2: PK: Cmax of Total Radioactivity	Part 2: PK: Cmax of Total Radioactivity	Day 1 up to Day 9 post dose
Part 2: Total Radioactivity Recovered in Urine and Feces	Part 2: Total Radioactivity Recovered in Urine and Feces	Day 1 up to Day 9 post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Bioavailability; ADME; Disposition; Radioactive
• Other Study ID Numbers: 18597; J2O-MC-EKBD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes