Clinical trial NCT06658626: A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)
Official title: An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-0616 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
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 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Cumulative Amount of Radioactivity Excreted in Urine (Aeu)
timeFrame: At designated timepoints (up to 15 days)
measure: Cumulative Amount of Radioactivity Excreted in Feces (Aef)
timeFrame: At designated timepoints (up to 15 days)
measure: Cumulative Percentage of Radioactivity Excreted in Urine (feu)
timeFrame: At designated timepoints (up to 15 days)
measure: Cumulative Percentage of Radioactivity Excreted in Feces (fef)
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax)
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax)
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Total Reactivity: AUC0-t
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Total Reactivity: AUC0-inf
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Total Reactivity: Cmax
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Total Reactivity: t1/2
timeFrame: At designated timepoints (up to 15 days)
measure: Plasma Total Reactivity: Tmax
timeFrame: At designated timepoints (up to 15 days)
measure: 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)
timeFrame: At designated timepoints (up to 15 days)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 29 days
measure: Number of Participants Who Discontinue the Study Due to an AE
timeFrame: Up to approximately 29 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit Inc. (Site 0001)
state: Wisconsin
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: