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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
IV Injection
Labcorp Clinical Research Unit Inc. (Site 0001)
Madison, Wisconsin, United States
Cumulative Amount of Radioactivity Excreted in Urine (Aeu)
Urine samples will be collected to determine the Aeu of \[¹⁴C\]enlicitide chloride.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to 15 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)
Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to 15 days)
Plasma Total Reactivity: Cmax
Plasma samples will be collected to determine the Cmax of total reactivity.
Time frame: 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.
Time frame: At designated timepoints (up to 15 days)
Plasma Total Reactivity: Tmax
Plasma samples will be collected to determine the Tmax of total reactivity.
Time frame: 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.
Time frame: At designated timepoints (up to 15 days)
Number of Participants Who Experience an Adverse Event (AE)
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.
Time frame: Up to approximately 29 days
Number of Participants Who Discontinue the Study Due to an AE
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.
Time frame: Up to approximately 29 days