A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)
- Registration Number
- NCT06592339
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1 MK-0616 Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2 MK-0616 Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule MK-0616 Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1 MK-0616 Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule MK-0616 Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2) MK-0616 Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.
- Primary Outcome Measures
Name Time Method 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 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 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
QPS-MRA, LLC-Early Phase
🇺🇸South Miami, Florida, United States