A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)
- Registration Number
- NCT06662396
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
The main inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive
The main exclusion criteria include but are not limited to the following:
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-6552 + Diltiazem Diltiazem Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552. MK-6552 + Diltiazem MK-6552 Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of MK-6552 Pre-dose and at designated time points up to 24 hours post dose Blood samples will be collected to determine the Cmax of MK-6552 in plasma.
- Secondary Outcome Measures
Name Time Method Time to Maximum Plasma Concentration (Tmax) of MK-6552 Pre-dose and at designated time points up to 96 hours post dose Blood samples will be collected to determine the Tmax of MK-6552 in plasma.
Concentration of MK-6552 at 6 Hours Postdose (C6h) Pre-dose and at designated time points up to 6 hours post dose Blood samples will be collected to determine the C6h of MK-6552 in plasma.
Concentration of MK-6552 at 8 Hours Postdose (C8h) Pre-dose and at designated time points up to 8 hours post dose Blood samples will be collected to determine the C8h of MK-6552 in plasma.
Apparent Clearance (CL/F) of MK-6552 Pre-dose and at designated time points up to 96 hours post dose Blood samples will be collected to determine the CL/F of MK-6552 in plasma.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552 Pre-dose and at designated time points up to 96 hours post dose Blood samples will be collected to determine the Vz/F of MK-6552 in plasma.
Apparent Terminal Half-Life (t1/2) of MK-6552 Pre-dose and at designated time points up to 96 hours post dose Blood samples will be collected to determine the t1/2 of MK-6552 in plasma.
Number of Participants Who Experience and Adverse Event (AEs) Up to approximately 20 days 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.
Number of Participants Who Discontinue Study Due to an AE Up to approximately 20 days 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.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 Pre-dose and at designated time points up to 96 hours post dose Blood samples will be collected to determine the AUC0-inf of MK-6552 in plasma.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552 Pre-dose and at designated time points up to 24 hours post dose Blood samples will be collected to determine the AUC0-24 of MK-6552 in plasma.
Trial Locations
- Locations (1)
ICON (Site 0001)
🇺🇸Lenexa, Kansas, United States