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Completed

NCT Number: NCT06049108

A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3871801), 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, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks including the screening period.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

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 18.5 to 32.0 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 LY3871801, related compounds, or any components of the formulation, or a history of significant atopy
  • Have received or intend to receive any vaccination within 30 days prior to dosing until the follow-up phone call
  • Have participated in a radiolabeled drug study, where exposures are known to the investigator or designee, within 4 months prior to check-in, or participated in a radiolabeled drug study, where exposures are not known to the investigator or designee, within 6 months prior to check-in

Treatment and study plan

[14C]-LY3871801

Drug

Administered orally

Primary outcomes

  1. Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to Day 7 post dose

    Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  2. Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to Day 7 post dose

    Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-∞]) of [¹⁴C]-LY3871801

    Time frame: Predose up to Day 7 post dose

    PK: AUC [0-∞] of [¹⁴C]-LY3871801

  2. PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood

    Time frame: Predose up to Day 7 post dose

    PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood

  3. PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801

    Time frame: Predose up to Day 7 post dose

    PK: Cmax of [¹⁴C]-LY3871801

  4. PK: Cmax of Total Radioactivity

    Time frame: Predose up to Day 7 post dose

    PK: Cmax of Total Radioactivity

  5. Total Radioactivity Recovered in Urine, Feces, and Expired Air

    Time frame: Predose up to Day 7 post dose

    Total Radioactivity Recovered in Urine, Feces, and Expired Air

  6. Total Number of Metabolites of LY3871801

    Time frame: Predose up to Day 7 post dose

    Total Number of Metabolites of LY3871801

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-LY3871801 in Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Jan 8, 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.

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