A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide decanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06691906

0616-025

MK-0616-025 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.

Enrollment: 40 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
• Medically healthy with no clinically significant medical history.

Exclusion criteria

• Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
• Has a history of cancer (malignancy).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Enlicitide Decanoate Treatment A

Experimental group

Description:

Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach.

Treatment:

Drug: Enlicitide decanoate

Enlicitide Decanoate Treatment B

Experimental group

Description:

Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach.

Treatment:

Drug: Enlicitide decanoate