A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide Chloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06814106

MK-0616-010 (Other Identifier)

0616-010

Details and patient eligibility

About

The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.

Enrollment: 37 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria include, but are not limited to:

• Is in good health
• Has a body mass index ≥19.0 and ≤26.0 kg/m^2, inclusive

Exclusion criteria

Exclusion criteria include, but are not limited to:

• Has a history of gastrointestinal disease
• Has a history of cancer (malignancy)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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37 participants in 3 patient groups

Enlicitide Chloride Panel A

Experimental group

Description:

Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast.

Treatment:

Drug: Placebo

Drug: Enlicitide Chloride

Enlicitide Chloride Panel B

Experimental group

Description:

Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).

Treatment:

Drug: Placebo

Drug: Enlicitide Chloride

Enlicitide Chloride Panel C

Experimental group

Description:

Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast).

Treatment:

Drug: Placebo

Drug: Enlicitide Chloride