Clinical trial NCT06814106: A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
Official title: A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0616 in Healthy Chinese Adult Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-07
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 2 months
measure: Number of Participants Who Discontinue the Study Treatment Due to an AE
timeFrame: Up to approximately 2 months
Secondary outcomes:
measure: Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 24 hours postdose)
measure: Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride
timeFrame: 24 hours postdose
measure: Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Predose and at designated timepoints (up to 8 days postdose)
measure: Panel C: AUC0-24 of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 24 hours postdose)
measure: Panel C: Cmax of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
measure: Panel C: Tmax of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
measure: Panel C: C24 of Enlicitide Chloride
timeFrame: 24 hours postdose
measure: Panel C: Apparent Terminal t1/2 of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
measure: Panel C: CL/F of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
measure: Panel C: Vz/F of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
measure: Panel C: Accumulation Ratio of Enlicitide Chloride
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
measure: Panel C: Percent of Reduction of Serum LDL-C
timeFrame: Predose and at designated timepoints (up to 14 days postdose)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
state: Shanghai
Study officials:
affiliation: Merck Sharpe & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: