A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
NCT ID: NCT06814106
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2023-03-06
2023-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
Enlicitide Chloride
Oral Capsule
Placebo
Placebo oral capsule matching enlicitide chloride
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).
Enlicitide Chloride
Oral Capsule
Placebo
Placebo oral capsule matching enlicitide chloride
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).
Enlicitide Chloride
Oral Capsule
Placebo
Placebo oral capsule matching enlicitide chloride
Interventions
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Enlicitide Chloride
Oral Capsule
Placebo
Placebo oral capsule matching enlicitide chloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a body mass index ≥19.0 and ≤26.0 kg/m\^2, inclusive
Exclusion Criteria
* Has a history of cancer (malignancy)
18 Years
50 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharpe & Dohme LLC
Locations
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Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
Shanghai, Shanghai Municipality, China
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-0616-010
Identifier Type: OTHER
Identifier Source: secondary_id
0616-010
Identifier Type: -
Identifier Source: org_study_id
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