A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)

NCT06658626 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-016MK-0616-016
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn what happens to enlicitide chloride labeled with \[¹⁴C\] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

• Cumulative Amount of Radioactivity Excreted in Urine (Aeu)

  Urine samples will be collected to determine the Aeu of \[¹⁴C\]enlicitide chloride.

  At designated timepoints (up to 15 days)

• Cumulative Amount of Radioactivity Excreted in Feces (Aef)

  Fecal samples will be collected to determine the Aef of \[¹⁴C\]enlicitide chloride.

  At designated timepoints (up to 15 days)

• Cumulative Percentage of Radioactivity Excreted in Urine (feu)

  Urine samples will be collected to determine the feu of \[¹⁴C\]enlicitide chloride.

  At designated timepoints (up to 15 days)

• Cumulative Percentage of Radioactivity Excreted in Feces (fef)

  Fecal samples will be collected to determine the fef of \[¹⁴C\]enlicitide chloride.

  At designated timepoints (up to 15 days)

• Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)

  Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.

  At designated timepoints (up to 15 days)

• Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)

  Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.

  At designated timepoints (up to 15 days)

• Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax)

  Plasma samples will be collected to determine the Cmax of enlicitide chloride.

  At designated timepoints (up to 15 days)

• Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)

  Plasma samples will be collected to determine the t1/2 of enlicitide chloride.

  At designated timepoints (up to 15 days)

• Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax)

  Plasma samples will be collected to determine the Tmax of enlicitide chloride.

  At designated timepoints (up to 15 days)

• Plasma Total Reactivity: AUC0-t

  Plasma samples will be collected to determine the AUC0-t of total reactivity.

  At designated timepoints (up to 15 days)

• Plasma Total Reactivity: AUC0-inf

  Plasma samples will be collected to determine the AUC0-inf of total reactivity.

  At designated timepoints (up to 15 days)

• Plasma Total Reactivity: Cmax

  Plasma samples will be collected to determine the Cmax of total reactivity.

  At designated timepoints (up to 15 days)

• Plasma Total Reactivity: t1/2

  Plasma samples will be collected to determine the t1/2 of total reactivity.

  At designated timepoints (up to 15 days)

• Plasma Total Reactivity: Tmax

  Plasma samples will be collected to determine the Tmax of total reactivity.

  At designated timepoints (up to 15 days)

• Enlicitide Chloride to Total Radioactivity Ratio of Area Under the Concentration-Time Curve from Time 0 to the Last Detectable Sample (enlicitide chloride AUC0-x/total radioactivity AUC0-x)

  Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.

  At designated timepoints (up to 15 days)

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 29 days

• Number of Participants Who Discontinue the Study Due to an AE

  Up to approximately 29 days

Study Arms (1)

[¹⁴C]Enlicitide chloride

EXPERIMENTAL

Participants will receive a single dose of \[¹⁴C\]enlicitide chloride on Day 1.

Drug: [¹⁴C]Enlicitide chloride

Interventions

[¹⁴C]Enlicitide chloride DRUG

IV Injection

Also known as: MK-0616

[¹⁴C]Enlicitide chloride

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health.
• Has a body mass index ≥18 and ≤32 kg/m\^2, inclusive.

You may not qualify if:

• Has a history of cancer.
• Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc. (Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: March 10, 2023
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)