Skip to main content
OpenTrials
Completed

NCT Number: NCT06592339

A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)

The goal of the study is to learn what happens to levels of MK-0616 in the blood when MK-0616 is given in different forms. Researchers believe that there is no effect on a healthy person's body if MK-0616 is given in different forms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS-MRA, LLC-Early Phase

South Miami, Florida, 33143, 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:

  • Is in good health before randomization
  • Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive

Exclusion criteria

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

  • Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)

Treatment and study plan

MK-0616

Drug

oral administration

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616

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

    Blood samples will be collected to determine the AUC0-inf of MK-0616.

  2. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of MK-0616

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

    Blood samples will be collected to determine the AUC0-24 of MK-0616.

  3. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-0616

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

    Blood samples will be collected to determine the AUC0-last of MK-0616.

  4. Maximum Plasma Concentration (Cmax) of MK-0616

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

    Blood samples will be collected to determine the Cmax of MK-0616.

  5. Maximum Plasma Concentration (C24) of MK-0616

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

    Blood samples will be collected to determine the C24 of MK-0616.

  6. Apparent Terminal Half-life (t1/2) of MK-0616

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

    Blood samples will be collected to determine the apparent t1/2 of MK-0616.

  7. Time to Maximum Plasma Concentration (Tmax) of MK-0616

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

    Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-0616.

Secondary 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 participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 approximately 2 months

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

An Open-Label, Randomized, Single-Dose, 3-Period, Crossover Study to Evaluate the Comparative Bioavailability of MK-0616 Capsules and Tablet Formulations in Healthy Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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.

Related clinical trials

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