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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06592339

Enrollment

Registered

2024-09-19

Start date

2022-10-25

Completion date

2022-12-29

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

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.

Interventions

DRUGMK-0616

oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Time to Maximum Plasma Concentration (Tmax) of MK-0616	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.
Maximum Plasma Concentration (C24) of MK-0616	Predose and at designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the C24 of MK-0616.
Apparent Terminal Half-life (t1/2) of MK-0616	Predose and at designated timepoints up to 168 hours postdose	Blood samples will be collected to determine the apparent t1/2 of MK-0616.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of MK-0616	Predose and at designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the AUC0-24 of MK-0616.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616	Predose and at designated timepoints up to 168 hours postdose	Blood samples will be collected to determine the AUC0-inf of MK-0616.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-0616	Predose and at designated timepoints up to 168 hours postdose	Blood samples will be collected to determine the AUC0-last of MK-0616.
Maximum Plasma Concentration (Cmax) of MK-0616	Predose and at designated timepoints up to 168 hours postdose	Blood samples will be collected to determine the Cmax of MK-0616.

Secondary

Measure	Time frame	Description
Number of Participants Who Discontinue Study Due to an AE	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.
Number of Participants Who Experience an Adverse Event (AE)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026