Study of Tirzepatide in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 14C Tirzepatide

• Registration Number: NCT04311424
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2020-07-28
• Primary Completion: 2020-10-02
• Study Completion: 2020-10-02
• Status Verified: 2022-06
• Results First Submitted: 2022-06-09
• Results First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Results First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
14C Tirzepatide	14C Tirzepatide	A single dose of \[14C\]-tirzepatide administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered	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	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 Outcome Measures

Name	Time	Method
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)	Pre-dose and up to 63 days post-dose	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable).
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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\[0-∞\]) of tirzepatide.
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	PK: Maximum Concentration (Cmax) of tirzepatide.
Total Number of Metabolites	Pre-dose and up to 63 days post-dose	Total Number of Metabolites.
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	PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).
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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\[0-∞\]) of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).

Trial Locations

Locations (1)

Covance Clinical Research Ltd; 🇬🇧 Leeds, West Yorkshire, United Kingdom