Clinical trial NCT06592339: A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of MK-0616
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-0616
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Maximum Plasma Concentration (Cmax) of MK-0616
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Maximum Plasma Concentration (C24) of MK-0616
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Apparent Terminal Half-life (t1/2) of MK-0616
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-0616
timeFrame: Predose and at designated timepoints up to 168 hours postdose
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 2 months
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 2 months
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC-Early Phase
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: