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

NCT ID: NCT05749848

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2023-04-18

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[¹⁴C]-LY3372689

Single dose of \[¹⁴C\]-LY3372689 administered orally.

Group Type: EXPERIMENTAL

[¹⁴C]-LY3372689

Intervention Type: DRUG

Administered orally.

Interventions

[¹⁴C]-LY3372689

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

LabCorp CRU, Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

I9X-MC-MTAF

Identifier Type: OTHER

Identifier Source: secondary_id

18430

Identifier Type: -

Identifier Source: org_study_id