Clinical trial NCT06772792: A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)
Official title: A Clinical Study to Evaluate the Effect of MK-0616 on the Pharmacokinetics of Alendronate in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
measure: Maximum Plasma Concentration (Cmax) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
measure: Time to Maximum Plasma Concentration (Tmax) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
measure: Apparent Terminal Half-Life (t1/2) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
measure: Apparent Clearance (CL/F) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
measure: Apparent Volume of Distribution (Vz/F) of Alendronate
timeFrame: At designated timepoints (up to approximately 10 hours post-dose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 8 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 3 weeks
measure: Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration
timeFrame: At designated timepoints (up to approximately 48 hours post-dose)
measure: Maximum Rate (Rmax) of Alendronate Excretion
timeFrame: At designated timepoints (up to approximately 48 hours post-dose)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: