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Completed

NCT Number: NCT06814106

A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)

The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Inclusion criteria

include, but are not limited to:

  • Is in good health
  • Has a body mass index ≥19.0 and ≤26.0 kg/m^2, inclusive

Exclusion criteria

Exclusion criteria

include, but are not limited to:

  • Has a history of gastrointestinal disease
  • Has a history of cancer (malignancy)

Treatment and study plan

Enlicitide Chloride

Drug

Oral Capsule

Other names: MK-0616

Placebo

Drug

Placebo oral capsule matching enlicitide chloride

Primary outcomes

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

    Time frame: Up to approximately 2 months

    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 the Study Treatment Due to an AE

    Time frame: Up to approximately 2 months

    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

Secondary outcomes

  1. Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

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

  2. Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride

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

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

  3. Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

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

  4. Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

    Blood samples will be collected to determine the Cmax of enlicitide chloride

  5. Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

    Blood samples will be collected to determine the Tmax of enlicitide chloride

  6. Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride

    Time frame: 24 hours postdose

    Blood samples will be collected to determine the C24 of enlicitide chloride

  7. Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

    Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride

  8. Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

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

  9. Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

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

  10. Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Predose and at designated timepoints (up to 8 days postdose)

    Blood samples will be collected to determine the percent of reduction of serum LDL-C

  11. Panel C: AUC0-24 of Enlicitide Chloride

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

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

  12. Panel C: Cmax of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

    Blood samples will be collected to determine the Cmax of enlicitide chloride

  13. Panel C: Tmax of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

    Blood samples will be collected to determine the Tmax of enlicitide chloride

  14. Panel C: C24 of Enlicitide Chloride

    Time frame: 24 hours postdose

    Blood samples will be collected to determine the C24 of enlicitide chloride

  15. Panel C: Apparent Terminal t1/2 of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

    Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride

  16. Panel C: CL/F of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

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

  17. Panel C: Vz/F of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

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

  18. Panel C: Accumulation Ratio of Enlicitide Chloride

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

    Blood samples will be collected to determine the accumulation ratio of enlicitide chloride

  19. Panel C: Percent of Reduction of Serum LDL-C

    Time frame: Predose and at designated timepoints (up to 14 days postdose)

    Blood samples will be collected to determine the percent of reduction of serum LDL-C

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0616 in Healthy Chinese Adult Participants.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2025
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.

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