Study of Tirzepatide in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT04311424
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
30 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 28, 2020
Status verified
Jun 2022
Primary completion
Oct 2, 2020
Completion
Oct 2, 2020

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 14C Tirzepatide
    A single dose of \[14C\]-tirzepatide administered subcutaneously (SC).

Primary Outcome Measure

Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose and up to 63 days post-dose ]

Related Studies