Clinical trial NCT04311424: Study of Tirzepatide in Healthy Participants
Official title: Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
timeFrame: Pre-dose and up to 63 days post-dose
measure: Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
timeFrame: Pre-dose and up to 63 days post-dose
Secondary outcomes:
measure: Total Number of Metabolites
timeFrame: Pre-dose and up to 63 days post-dose
measure: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)
timeFrame: Pre-dose and up to 63 days post-dose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide
timeFrame: Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
measure: PK: Maximum Concentration (Cmax) of Tirzepatide
timeFrame: Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity
timeFrame: Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
measure: PK: Maximum Concentration (Cmax) of Total Radioactivity
timeFrame: Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Ltd
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: