Healthy
Conditions
Brief summary
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.
Interventions
DRUGAlendronate
Oral administration
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Has no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs) * Has a body mass index (BMI) ≥18.0 kg/m\^2 and ≤32.0 kg/m\^2 (inclusive)
Exclusion criteria
* Has a history or presence of abnormalities of the esophagus which delay emptying such as stricture or achalasia * Has a history of cancer (malignancy) * Has a history of gastrointestinal disease which may affect food and drug absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution (Vz/F) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine Vz/F of alendronate. |
| Maximum Plasma Concentration (Cmax) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine the Cmax of alendronate. |
| Time to Maximum Plasma Concentration (Tmax) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine the Tmax of alendronate. |
| Apparent Terminal Half-Life (t1/2) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine the t1/2 of alendronate. |
| Apparent Clearance (CL/F) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine the CL/F of alendronate. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine the AUC0-Last of alendronate. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate | At designated timepoints (up to approximately 10 hours post-dose) | Blood samples will be collected to determine the AUC0-Inf of alendronate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 3 weeks | 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. |
| Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration | At designated timepoints (up to approximately 48 hours post-dose) | Urine samples will be collected to determine the Ae0-48 of alendronate. |
| Maximum Rate (Rmax) of Alendronate Excretion | At designated timepoints (up to approximately 48 hours post-dose) | Urine samples will be collected to determine the Rmax of alendronate excretion. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 8 weeks | 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. |
Countries
United States
Outcome results
None listed