The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)

NCT06658652 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-022MK-0616
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection. The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate

  Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate

  Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.

  Pre-dose and at designated time points up to 24 hours postdose

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate

  Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate

  Blood samples will be collected to determine the Cmax of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate

  Blood samples will be collected to determine the Tmax of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Lag Time (tlag) of Enlicitide Decanoate in Plasma

  Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate

  Blood samples will be collected to determine the t1/2 of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Apparent Clearance (CL/F) of Enlicitide Decanoate

  Blood samples will be collected to determine the CL/F of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate

  Blood samples will be collected to determine the Vz/F of enlicitide decanoate.

  Pre-dose and at designated time points up to 1 week postdose

Secondary Outcomes (2)

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

  Up to 14 days postdose

• Number of Participants Who Discontinue Study Due to an AE

  Up to 14 days postdose

Study Arms (2)

Enlicitide Decanoate Food Effect

EXPERIMENTAL

Participants will be administered enlicitide decanoate on Day 1 with or without food.

Drug: Enlicitide decanoate

Enlicitide Decanoate Water Effect

EXPERIMENTAL

Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.

Drug: Enlicitide decanoate

Interventions

Enlicitide decanoate DRUG

Oral tablet

Also known as: MK-0616

Enlicitide Decanoate Food Effect; Enlicitide Decanoate Water Effect

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2
• Is medically healthy with no clinically significant medical history

You may not qualify if:

• Has history of gastrointestinal disease which may affect food and drug absorption
• Has history of cancer (malignancy).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 24, 2023
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)