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Completed

NCT Number: NCT04311424

Study of Tirzepatide in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Ltd

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C Tirzepatide

Drug

Administered SC.

Other names: LY3298176

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Total Number of Metabolites

    Time frame: Pre-dose and up to 63 days post-dose

    Total Number of Metabolites.

  2. Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)

    Time frame: Pre-dose and up to 63 days post-dose

    Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable).

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide

    Time frame: 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.

  4. PK: Maximum Concentration (Cmax) of Tirzepatide

    Time frame: 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.

  5. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity

    Time frame: 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).

  6. PK: Maximum Concentration (Cmax) of Total Radioactivity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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