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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749848
• Other study ID #: 18430
• Secondary ID: I9X-MC-MTAF
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2023
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [¹4C]-LY3372689
Administered orally.

Locations

Country	Name	City	State
United States	LabCorp CRU, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 17 post dose
Primary	Fecal 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
Secondary	Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-8)) of Total Radioactivity and [¹4C]-LY3372689	PK: AUC (0-8) of Total Radioactivity and [¹4C]-LY3372689	Predose up to Day 17 post dose
Secondary	PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹4C]-LY3372689	PK: Cmax of Total Radioactivity and [¹4C]-LY3372689	Predose up to Day 17 post dose
Secondary	PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹4C]-LY3372689	PK: AUC (0-tlast) of Total Radioactivity and [¹4C]-LY3372689	Predose up to Day 17 post dose
Secondary	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Predose up to Day 17 post dose
Secondary	Total Number of Metabolites of LY3372689	Total Number of Metabolites of LY3372689	Predose up to 120 hour post dose