Study of Tirzepatide in Healthy Participants

• Status: Completed
• Trial end date: 2020-10-02
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

Criteria

Inclusion Criteria:

• Overtly healthy males as determined by medical history, physical examination, and other screening procedures

• Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening

• Are willing to be available for the full duration of the study

Exclusion Criteria:

• Have known allergies to tirzepatide or related compounds

• Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study

• Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography [CT] scans, barium meal, being employed in a job requiring radiation exposure monitoring)

• Have participated in any clinical trial involving a radiolabeled substance within the past 12 months