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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2024-06-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

NCT00803790

Osteoporosis

COMPLETED PHASE1

A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)

NCT00480662

Paget's Disease of Bone

COMPLETED PHASE3

A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

NCT00092079

Osteoporosis Vitamin D Deficiency

COMPLETED PHASE3

A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

NCT00806416

Osteoporosis

COMPLETED PHASE1

A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

NCT00092027

Postmenopausal Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Oral administration

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.

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Oral administration

Enlicitide Decanoate

Intervention Type DRUG

Oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alendronate

Oral administration

Intervention Type DRUG

Enlicitide Decanoate

Oral administration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fosamax® MK-0616

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes