Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
14C Tirzepatide
A single dose of [14C]-tirzepatide administered subcutaneously (SC).
Intervention: 14C Tirzepatide (Drug)
Outcomes
Primary Outcomes
Fecal 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
Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.
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
Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.
Secondary Outcomes
- Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)(Pre-dose and up to 63 days post-dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide(Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose)
- PK: Maximum Concentration (Cmax) of Tirzepatide(Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose)
- Total Number of Metabolites(Pre-dose and up to 63 days post-dose)
- PK: Maximum Concentration (Cmax) of Total Radioactivity(Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity(Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose)