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Completed

NCT Number: NCT06691906

A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)

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.

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Key information

Conditions

Healthy

Age range

19 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

  • 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.

Exclusion criteria

  • Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
  • Has a 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 0 to 24 hours (AUC0-24) of enlicitide decanoate

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

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

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

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

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

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

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

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

  4. Maximum Plasma Concentration (Cmax) of enlicitide decanoate

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

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

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

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

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

  7. Apparent Clearance (CL/F) of enlicitide decanoate

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

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

  8. Apparent Volume of Distribution During Terminal Phase (Vz/F) of enlicitide decanoate

    Time frame: Predose and at designated timepoints (up to 168 hours 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 approximately 44 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

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

    Time frame: Up to approximately 44 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the 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 Relative Bioavailability of MK-0616 Formulations in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2024
Registry last updated
Nov 18, 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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