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

NCT06772792 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-027MK-0616-027
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  At designated timepoints (up to approximately 10 hours post-dose)

Secondary Outcomes (4)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 8 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 3 weeks

• 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)

• Maximum Rate (Rmax) of Alendronate Excretion

  At designated timepoints (up to approximately 48 hours post-dose)

Study Arms (2)

Alendronate

EXPERIMENTAL

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

Alendronate + Enlicitide Decanoate

EXPERIMENTAL

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: Alendronate; Drug: Enlicitide Decanoate

Interventions

Alendronate DRUG

Oral administration

Also known as: Fosamax®

Alendronate; Alendronate + Enlicitide Decanoate

Enlicitide Decanoate DRUG

Oral administration

Also known as: MK-0616

Alendronate + Enlicitide Decanoate

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Alendronate; MK-0616

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: April 23, 2024
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)