NCT06691906

Brief Summary

The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_1 healthy

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

Study Start

First participant enrolled

March 18, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 13, 2024

Last Update Submit

November 13, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

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

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

    Predose and at designated timepoints (up to 24 hours postdose)

  • Area Under the Concentration-Time Curve from 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate

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

    Predose and at designated timepoints (up to 168 hours postdose)

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

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

    Predose and at designated timepoints (up to 168 hours postdose)

  • Maximum Plasma Concentration (Cmax) of enlicitide decanoate

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

    Predose and at designated timepoints (up to 168 hours postdose)

  • Time to Maximum Plasma Concentration (Tmax) of enlicitide decanoate

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

    Predose and at designated timepoints (up to 168 hours postdose)

  • Apparent Terminal Half-Life (t1/2) of enlicitide decanoate

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

    Predose and at designated timepoints (up to 168 hours postdose)

  • Apparent Clearance (CL/F) of enlicitide decanoate

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

    Predose and at designated timepoints (up to 168 hours 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.

    Predose and at designated timepoints (up to 168 hours postdose)

Secondary Outcomes (2)

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

    Up to approximately 44 days

  • Number of Participants Who Discontinue Study Treatment Due to an AE

    Up to approximately 44 days

Study Arms (2)

Enlicitide Decanoate Treatment A

EXPERIMENTAL

Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach.

Drug: Enlicitide decanoate

Enlicitide Decanoate Treatment B

EXPERIMENTAL

Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach.

Drug: Enlicitide decanoate

Interventions

Enlicitide decanoateDRUG

Oral tablet

Also known as: MK-0616
Enlicitide Decanoate Treatment AEnlicitide Decanoate Treatment B

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
  • Medically healthy with no clinically significant medical history.

You may not qualify if:

  • Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
  • Has a history of cancer (malignancy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, 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

November 13, 2024

First Posted

November 18, 2024

Study Start

March 18, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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

More information

Locations

US(1)