Healthy
Conditions
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.
Interventions
DRUG[¹⁴C]Enlicitide chloride
IV Injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed