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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Alendronate; Drug: Enlicitide Decanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06772792

0616-027

MK-0616-027 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Alendronate

Experimental group

Description:

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.

Treatment:

Drug: Alendronate

Alendronate + Enlicitide Decanoate

Experimental group

Description:

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.

Treatment:

Drug: Enlicitide Decanoate

Drug: Alendronate