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

NCT06814106 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-010MK-0616-010
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  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

  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 Outcomes (19)

• Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (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

  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

  Predose and at designated timepoints (up to 8 days postdose)

• Panels A and B: Maximum Plasma Concentration (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

  Predose and at designated timepoints (up to 8 days postdose)

Study Arms (3)

Enlicitide Chloride Panel A

EXPERIMENTAL

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.

Drug: Enlicitide Chloride; Drug: Placebo

Enlicitide Chloride Panel B

EXPERIMENTAL

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).

Drug: Enlicitide Chloride; Drug: Placebo

Enlicitide Chloride Panel C

EXPERIMENTAL

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

Drug: Enlicitide Chloride; Drug: Placebo

Interventions

Enlicitide Chloride DRUG

Oral Capsule

Also known as: MK-0616

Enlicitide Chloride Panel A; Enlicitide Chloride Panel B; Enlicitide Chloride Panel C

Placebo DRUG

Placebo oral capsule matching enlicitide chloride

Enlicitide Chloride Panel A; Enlicitide Chloride Panel B; Enlicitide Chloride Panel C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)

Shanghai, Shanghai Municipality, 200032, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharpe & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Additional Roles Masked: Sponsor
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: March 6, 2023
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)