NCT06609512

Brief Summary

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

September 20, 2024

Last Update Submit

February 6, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma

    AUC0-inf of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma

    AUC0-24 of enlicitide in plasma will be determined.

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

  • Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma

    AUC0-last of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Maximum plasma concentration (Cmax) of enlicitide in plasma

    Cmax of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Time to maximum plasma concentration (Tmax) of enlicitide in plasma

    Tmax of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Apparent terminal half-life (t1/2) of enlicitide in plasma

    t1/2 of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Apparent Clearance (CL/F) of enlicitide in plasma

    CL/F of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma

    Vz/F of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

  • Lag Time (tlag) of enlicitide in plasma

    tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.

    Pre-dose and at designated time points up to 168 hours post dose

Secondary Outcomes (2)

  • Number of participants who experience one or more adverse events (AEs)

    Up to ~ 14 days

  • Number of participants who discontinue study intervention due to an AE

    Up to ~ 14 days

Study Arms (4)

Enlicitide Treatment A

EXPERIMENTAL

Participants receive single oral dose of enlicitide after 8-hour overnight fast.

Drug: Enlicitide

Enlicitide Treatment B

EXPERIMENTAL

Participants receive single oral dose of enlicitide 4 hours after morning meal.

Drug: Enlicitide

Enlicitide Treatment C

EXPERIMENTAL

Participants receive single oral dose of enlicitide 3 hours after morning meal.

Drug: Enlicitide

Enlicitide Treatment D

EXPERIMENTAL

Participants receive single oral dose of enlicitide 2 hours after morning meal.

Drug: Enlicitide

Interventions

EnlicitideDRUG

Oral Tablet

Also known as: MK-0616, enlicitide decanoate
Enlicitide Treatment AEnlicitide Treatment BEnlicitide Treatment CEnlicitide Treatment D

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

You may not qualify if:

  • History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
  • History of cancer (malignancy)
  • Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
  • History of a major surgery
  • Is lactose intolerant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

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

September 20, 2024

First Posted

September 24, 2024

Study Start

October 21, 2024

Primary Completion

January 13, 2025

Study Completion

January 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(1)