A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male Participants
- Conditions
- Healthy
- Interventions
- Drug: [¹⁴C]-LY3372689
- Registration Number
- NCT05749848
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [¹⁴C]-LY3372689 [¹⁴C]-LY3372689 Single dose of \[¹⁴C\]-LY3372689 administered orally.
- Primary Outcome Measures
Name Time Method Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Predose up to Day 17 post dose Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered 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 Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689 Predose up to Day 17 post dose PK: AUC (0-∞) of Total Radioactivity and \[¹⁴C\]-LY3372689
PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689 Predose up to Day 17 post dose PK: AUC (0-tlast) of Total Radioactivity and \[¹⁴C\]-LY3372689
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) Predose up to Day 17 post dose Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689 Predose up to Day 17 post dose PK: Cmax of Total Radioactivity and \[¹⁴C\]-LY3372689
Total Number of Metabolites of LY3372689 Predose up to 120 hour post dose Total Number of Metabolites of LY3372689
Trial Locations
- Locations (1)
LabCorp CRU, Inc.
🇺🇸Madison, Wisconsin, United States