The goal of this study is to learn what happens to a single dose of alendronate over time in a healthy participant's body when the participant is given a single dose of enlicitide decanoate. Researchers want to learn how safe and tolerable is the co-administration of enlicitide decanoate and alendronate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Oral administration
Oral administration
Celerion (Site 0001)
Lincoln, Nebraska, United States
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate
Blood samples will be collected to determine the AUC0-Last of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate
Blood samples will be collected to determine the AUC0-Inf of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Maximum Plasma Concentration (Cmax) of Alendronate
Blood samples will be collected to determine the Cmax of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Alendronate
Blood samples will be collected to determine the Tmax of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Apparent Terminal Half-Life (t1/2) of Alendronate
Blood samples will be collected to determine the t1/2 of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Apparent Clearance (CL/F) of Alendronate
Blood samples will be collected to determine the CL/F of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Apparent Volume of Distribution (Vz/F) of Alendronate
Blood samples will be collected to determine Vz/F of alendronate.
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
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Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 3 weeks
Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration
Urine samples will be collected to determine the Ae0-48 of alendronate.
Time frame: At designated timepoints (up to approximately 48 hours post-dose)
Maximum Rate (Rmax) of Alendronate Excretion
Urine samples will be collected to determine the Rmax of alendronate excretion.
Time frame: At designated timepoints (up to approximately 48 hours post-dose)