Skip to main content
OpenTrials
Completed

NCT Number: NCT06342596

A Study of Carbon-14-Labelled [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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Holbeck, Leeds, LS11 9EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]-LY3473329

Drug

Administered orally

LY3473329

Drug

Administered orally

Primary outcomes

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

  2. 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 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

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

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: F of LY3473329

Secondary outcomes

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

    Time frame: Day 1 up to Day 29 post dose

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

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

    Time frame: Day 1 up to Day 29 post dose

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

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

    Time frame: Day 1 up to Day 29 post dose

    Part 1: PK: AUC(0-∞) of LY3473329

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

    Time frame: Day 1 up to Day 29 post dose

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

  5. Part 1: PK: Maximum Concentration (Cmax) of LY3473329

    Time frame: Day 1 up to Day 29 post dose

    Part 1: PK: Cmax of LY3473329

  6. Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity

    Time frame: Day 1 up to Day 29 post dose

    Part 1: PK: Cmax of Total Radioactivity

  7. Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)

    Time frame: Day 1 up to Day 29 post dose

    Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)

  8. Part 1: Total Number of Metabolites of LY3473329

    Time frame: Day 1 up to Day 29 post dose

    Part 1: Total Number of Metabolites of LY3473329

  9. Part 2: PK: AUC (0-∞) of LY3473329

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: AUC (0-∞) of LY3473329

  10. Part 2: PK: AUC (0-∞) of [14C]-LY3473329

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: AUC (0-∞) of [14C]-LY3473329

  11. Part 2: PK: AUC (0-∞) of Total Radioactivity

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: AUC (0-∞) of Total Radioactivity

  12. Part 2: PK: Cmax of LY3473329

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: Cmax of LY3473329

  13. Part 2: PK: Cmax of [14C]-LY3473329

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: Cmax of [14C]-LY3473329

  14. Part 2: PK: Cmax of Total Radioactivity

    Time frame: Day 1 up to Day 9 post dose

    Part 2: PK: Cmax of Total Radioactivity

  15. Part 2: Total Radioactivity Recovered in Urine and Feces

    Time frame: Day 1 up to Day 9 post dose

    Part 2: Total Radioactivity Recovered in Urine and Feces

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.