Study of Tirzepatide in Healthy Participants

Healthy Clinical Trial

Official title:

Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311424
• Other study ID #: 17378
• Secondary ID: I8F-MC-GPHX2019-
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2020
• Est. completion date: October 2, 2020

Study information

• Verified date: June 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 14C Tirzepatide
Administered SC.

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Ltd	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary 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
Primary	Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered	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
Secondary	Total Number of Metabolites	Total Number of Metabolites.	Pre-dose and up to 63 days post-dose
Secondary	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable).	Pre-dose and up to 63 days post-dose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-8]) of Tirzepatide	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-8]) 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
Secondary	PK: Maximum Concentration (Cmax) 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
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-8]) of Total Radioactivity	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-8]) of Total Radioactivity. Total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL).	Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
Secondary	PK: Maximum Concentration (Cmax) of Total Radioactivity	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).	Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose