Clinical trial NCT06662396: A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)
Official title: A Study to Evaluate the Effects of Coadministration of Diltiazem on the Plasma Pharmacokinetics of a Single Dose of MK-6552 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of MK-6552
timeFrame: Pre-dose and at designated time points up to 24 hours post dose
Secondary outcomes:
measure: Number of Participants Who Experience and Adverse Event (AEs)
timeFrame: Up to approximately 20 days
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 20 days
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
timeFrame: Pre-dose and at designated time points up to 96 hours post dose
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552
timeFrame: Pre-dose and at designated time points up to 24 hours post dose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-6552
timeFrame: Pre-dose and at designated time points up to 96 hours post dose
measure: Concentration of MK-6552 at 6 Hours Postdose (C6h)
timeFrame: Pre-dose and at designated time points up to 6 hours post dose
measure: Concentration of MK-6552 at 8 Hours Postdose (C8h)
timeFrame: Pre-dose and at designated time points up to 8 hours post dose
measure: Apparent Clearance (CL/F) of MK-6552
timeFrame: Pre-dose and at designated time points up to 96 hours post dose
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
timeFrame: Pre-dose and at designated time points up to 96 hours post dose
measure: Apparent Terminal Half-Life (t1/2) of MK-6552
timeFrame: Pre-dose and at designated time points up to 96 hours post dose
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON (Site 0001)
state: Kansas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: