A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)
- Registration Number
- NCT06658626
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- Is in good health.
- Has a body mass index ≥18 and ≤32 kg/m^2, inclusive.
- Has a history of cancer.
- Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [¹⁴C]Enlicitide chloride [¹⁴C]Enlicitide chloride Participants will receive a single dose of \[¹⁴C\]enlicitide chloride on Day 1.
- Primary Outcome Measures
Name Time Method Cumulative Percentage of Radioactivity Excreted in Feces (fef) At designated timepoints (up to 15 days) Fecal samples will be collected to determine the fef of \[¹⁴C\]enlicitide chloride.
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) At designated timepoints (up to 15 days) Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) At designated timepoints (up to 15 days) Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.
Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax) At designated timepoints (up to 15 days) Plasma samples will be collected to determine the Cmax of enlicitide chloride.
Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2) At designated timepoints (up to 15 days) Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax) At designated timepoints (up to 15 days) Plasma samples will be collected to determine the Tmax of enlicitide chloride.
Plasma Total Reactivity: AUC0-t At designated timepoints (up to 15 days) Plasma samples will be collected to determine the AUC0-t of total reactivity.
Plasma Total Reactivity: AUC0-inf At designated timepoints (up to 15 days) Plasma samples will be collected to determine the AUC0-inf of total reactivity.
Plasma Total Reactivity: Cmax At designated timepoints (up to 15 days) Plasma samples will be collected to determine the Cmax of total reactivity.
Plasma Total Reactivity: t1/2 At designated timepoints (up to 15 days) Plasma samples will be collected to determine the t1/2 of total reactivity.
Plasma Total Reactivity: Tmax At designated timepoints (up to 15 days) Plasma samples will be collected to determine the Tmax of total reactivity.
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) At designated timepoints (up to 15 days) Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.
Cumulative Amount of Radioactivity Excreted in Urine (Aeu) At designated timepoints (up to 15 days) Urine samples will be collected to determine the Aeu of \[¹⁴C\]enlicitide chloride.
Cumulative Amount of Radioactivity Excreted in Feces (Aef) At designated timepoints (up to 15 days) Fecal samples will be collected to determine the Aef of \[¹⁴C\]enlicitide chloride.
Cumulative Percentage of Radioactivity Excreted in Urine (feu) At designated timepoints (up to 15 days) Urine samples will be collected to determine the feu of \[¹⁴C\]enlicitide chloride.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 29 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue the Study Due to an AE Up to approximately 29 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Inc. (Site 0001)
🇺🇸Madison, Wisconsin, United States