A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
February 3, 2025 updated by: Merck Sharp & Dohme LLC
A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0616 in Healthy Chinese Adult Participants.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
Oral Capsule
Other Names:
Placebo oral capsule matching enlicitide chloride
|
|
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). |
Oral Capsule
Other Names:
Placebo oral capsule matching enlicitide chloride
|
|
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).
|
Oral Capsule
Other Names:
Placebo oral capsule matching enlicitide chloride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 2 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
|
Up to approximately 2 months
|
|
Number of Participants Who Discontinue the Study Treatment Due to an AE
Time Frame: Up to approximately 2 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
|
Up to approximately 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the AUC0-inf of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 24 hours postdose)
|
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
|
Predose and at designated timepoints (up to 24 hours postdose)
|
|
Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the AUC0-last of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the Cmax of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the Tmax of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride
Time Frame: 24 hours postdose
|
Blood samples will be collected to determine the C24 of enlicitide chloride
|
24 hours postdose
|
|
Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the CL/F of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the Vz/F of enlicitide chloride
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Predose and at designated timepoints (up to 8 days postdose)
|
Blood samples will be collected to determine the percent of reduction of serum LDL-C
|
Predose and at designated timepoints (up to 8 days postdose)
|
|
Panel C: AUC0-24 of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 24 hours postdose)
|
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
|
Predose and at designated timepoints (up to 24 hours postdose)
|
|
Panel C: Cmax of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the Cmax of enlicitide chloride
|
Predose and at designated timepoints (up to 14 days postdose)
|
|
Panel C: Tmax of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the Tmax of enlicitide chloride
|
Predose and at designated timepoints (up to 14 days postdose)
|
|
Panel C: C24 of Enlicitide Chloride
Time Frame: 24 hours postdose
|
Blood samples will be collected to determine the C24 of enlicitide chloride
|
24 hours postdose
|
|
Panel C: Apparent Terminal t1/2 of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride
|
Predose and at designated timepoints (up to 14 days postdose)
|
|
Panel C: CL/F of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the CL/F of enlicitide chloride
|
Predose and at designated timepoints (up to 14 days postdose)
|
|
Panel C: Vz/F of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the Vz/F of enlicitide chloride
|
Predose and at designated timepoints (up to 14 days postdose)
|
|
Panel C: Accumulation Ratio of Enlicitide Chloride
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the accumulation ratio of enlicitide chloride
|
Predose and at designated timepoints (up to 14 days postdose)
|
|
Panel C: Percent of Reduction of Serum LDL-C
Time Frame: Predose and at designated timepoints (up to 14 days postdose)
|
Blood samples will be collected to determine the percent of reduction of serum LDL-C
|
Predose and at designated timepoints (up to 14 days postdose)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharpe & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2023
Primary Completion (Actual)
May 8, 2023
Study Completion (Actual)
May 8, 2023
Study Registration Dates
First Submitted
February 3, 2025
First Submitted That Met QC Criteria
February 3, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 0616-010
- MK-0616-010 (Other Identifier: MSD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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