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Completed

NCT Number: NCT05749848

A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3372689), 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 about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

LabCorp CRU, Inc.

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 within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
  • Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose of LY3372689 may participate in this trial.

Exclusion criteria

  • Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in
  • Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Have evidence of significant active neuropsychiatric disease, as determined by the investigator
  • Have participated in >3 radiolabeled drug studies in the last 12 months

Treatment and study plan

[¹⁴C]-LY3372689

Drug

Administered orally.

Primary outcomes

  1. Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to Day 17 post dose

    Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  2. Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to Day 17 post dose

    Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689

    Time frame: Predose up to Day 17 post dose

    PK: AUC (0-∞) of Total Radioactivity and [¹⁴C]-LY3372689

  2. PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689

    Time frame: Predose up to Day 17 post dose

    PK: Cmax of Total Radioactivity and [¹⁴C]-LY3372689

  3. PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689

    Time frame: Predose up to Day 17 post dose

    PK: AUC (0-tlast) of Total Radioactivity and [¹⁴C]-LY3372689

  4. Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)

    Time frame: Predose up to Day 17 post dose

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

  5. Total Number of Metabolites of LY3372689

    Time frame: Predose up to 120 hour post dose

    Total Number of Metabolites of LY3372689

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Open-Label Study to Assess the Disposition of [14C]-LY3372689 Following Oral Administration in Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Apr 20, 2023

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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