Study of Tirzepatide in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: 14C Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04311424

2019-003664-44 (EudraCT Number)

17378

I8F-MC-GPHX (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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