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

February 14, 2025 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Effect of MK-0616 on the Pharmacokinetics of Alendronate in Healthy Adult Participants

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Alendronate
Oral administration
Other Names:
  • Fosamax®
Experimental: Alendronate + 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.
Drug: Enlicitide Decanoate
Oral administration
Other Names:
  • MK-0616
Drug: Alendronate
Oral administration
Other Names:
  • Fosamax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the AUC0-Last of alendronate.
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
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the AUC0-Inf of alendronate.
At designated timepoints (up to approximately 10 hours post-dose)
Maximum Plasma Concentration (Cmax) of Alendronate
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the Cmax of alendronate.
At designated timepoints (up to approximately 10 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Alendronate
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the Tmax of alendronate.
At designated timepoints (up to approximately 10 hours post-dose)
Apparent Terminal Half-Life (t1/2) of Alendronate
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the t1/2 of alendronate.
At designated timepoints (up to approximately 10 hours post-dose)
Apparent Clearance (CL/F) of Alendronate
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the CL/F of alendronate.
At designated timepoints (up to approximately 10 hours post-dose)
Apparent Volume of Distribution (Vz/F) of Alendronate
Time Frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine Vz/F of alendronate.
At designated timepoints (up to approximately 10 hours post-dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: 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.
Up to approximately 8 weeks
Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration
Time Frame: At designated timepoints (up to approximately 48 hours post-dose)
Urine samples will be collected to determine the Ae0-48 of alendronate.
At designated timepoints (up to approximately 48 hours post-dose)
Maximum Rate (Rmax) of Alendronate Excretion
Time Frame: At designated timepoints (up to approximately 48 hours post-dose)
Urine samples will be collected to determine the Rmax of alendronate excretion.
At designated timepoints (up to approximately 48 hours post-dose)
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: 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.
Up to approximately 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Actual)

June 21, 2024

Study Completion (Actual)

June 21, 2024

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-027
  • MK-0616-027 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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