Skip to main content
OpenTrials
Completed

NCT Number: NCT06609512

A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

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

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • 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

Treatment and study plan

Enlicitide

Drug

Oral Tablet

Other names: MK-0616, enlicitide decanoate

Primary outcomes

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

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

    AUC0-inf of enlicitide in plasma will be determined.

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

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

    AUC0-24 of enlicitide in plasma will be determined.

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

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

    AUC0-last of enlicitide in plasma will be determined.

  4. Maximum plasma concentration (Cmax) of enlicitide in plasma

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

    Cmax of enlicitide in plasma will be determined.

  5. Time to maximum plasma concentration (Tmax) of enlicitide in plasma

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

    Tmax of enlicitide in plasma will be determined.

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

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

    t1/2 of enlicitide in plasma will be determined.

  7. Apparent Clearance (CL/F) of enlicitide in plasma

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

    CL/F of enlicitide in plasma will be determined.

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

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

    Vz/F of enlicitide in plasma will be determined.

  9. Lag Time (tlag) of enlicitide in plasma

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

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

Secondary outcomes

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

    Time frame: Up to ~ 14 days

    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.

  2. Number of participants who discontinue study intervention due to an AE

    Time frame: Up to ~ 14 days

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effect of Fasting Duration on the Pharmacokinetics of the Enlicitide in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.