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Completed

NCT Number: NCT06658652

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

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.

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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)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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

Exclusion criteria

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

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

Treatment and study plan

Enlicitide Decanoate

Drug

Oral tablet

Other names: MK-0616

Primary outcomes

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

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

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

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

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

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

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

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

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

  4. Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate

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

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

  5. Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate

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

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

  6. Lag Time (tlag) of Enlicitide Decanoate in Plasma

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

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

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

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

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

  8. Apparent Clearance (CL/F) of Enlicitide Decanoate

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

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

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

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

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

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to 14 days postdose

    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. The number of participants who experience an AE will be reported.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to 14 days postdose

    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. The number of participants who discontinue study due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effect of Food and Water Volume on the Pharmacokinetics of the MK-0616 Final Market Formulation in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

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.

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