A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Alendronate; Drug: Enlicitide Decanoate

• Registration Number: NCT06772792
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alendronate	Alendronate	Participants receive a single oral dose of alendronate on Day 1 OR participants receive a single oral dose of alendronate on Day 15 depending on randomization.
Alendronate + Enlicitide Decanoate	Alendronate	Participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 1 OR participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 15 depending on randomization.
Alendronate + Enlicitide Decanoate	Enlicitide Decanoate	Participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 1 OR participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 15 depending on randomization.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Celerion (Site 0001); 🇺🇸 Lincoln, Nebraska, United States