Clinical trial NCT06818968: A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)
Official title: A 2-period, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-dose Pharmacokinetics of MK-6916 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 30
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 goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 in the body when it is given with or without another medicine called diltiazem.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has a body-mass index (BMI) 18 to 32 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
* Has a history of cancer (malignancy)
* Has a history of cardiac arrhythmia or recurrent unexplained syncopal events
* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome
* Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916
timeFrame: Predose and at designated time points (up to 8 weeks)
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916
timeFrame: Predose and at designated time points (up to 24 hours)
measure: Plasma Concentration at 24 Hours (C24) of MK-6916
timeFrame: Predose and at designated time points (up to 24 hours)
measure: Plasma Concentration at 12 Hours (C12) of MK-6916
timeFrame: Predose and at designated time points (up to 12 hours)
measure: Maximum Plasma Concentration (Cmax) of MK-6916
timeFrame: Predose and at designated time points (up to 8 weeks)
measure: Time to Maximum Plasma Concentration (Tmax) of MK-6916
timeFrame: Predose and at designated time points (up to 8 weeks)
measure: Apparent Clearance (CL/F) of MK-6916
timeFrame: Predose and at designated time points (up to 8 weeks)
measure: Apparent Volume of Distribution (Vz/F) of MK-6916
timeFrame: Predose and at designated time points (up to 8 weeks)
measure: Apparent Terminal Half-life (t1/2) of MK-6916
timeFrame: Predose and at designated time points (up to 8 weeks)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 8 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 8 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea CRU, Madison ( Site 0001)
state: Wisconsin
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: