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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06814106
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide Chloride — DRUG
    Oral Capsule
  • Placebo — DRUG
    Placebo oral capsule matching enlicitide chloride

Study Details

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.

Key Dates

Start date
Mar 6, 2023
Status verified
Feb 2025
Primary completion
May 8, 2023
Completion
May 8, 2023

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Enlicitide Chloride Panel A
    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.
  • Experimental: Enlicitide Chloride Panel B
    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).
  • Experimental: Enlicitide Chloride Panel C
    Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast).

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 2 months ]

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