A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)

Phase 1

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: MK-6916; Drug: Diltiazem

• Registration Number: NCT06818968
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Study Start: 2025-02-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-05-27
• Study Completion: 2025-05-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-6916 + Diltiazem	MK-6916	Participants will receive MK-6916 and diltiazem orally.
MK-6916 + Diltiazem	Diltiazem	Participants will receive MK-6916 and diltiazem orally.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916	Predose and at designated time points (up to 8 weeks)	Blood samples will be collected to determine the AUC0-inf of MK-6916.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916	Predose and at designated time points (up to 24 hours)	Blood samples will be collected to determine the AUC0-24 of MK-6916.
Plasma Concentration at 24 Hours (C24) of MK-6916	Predose and at designated time points (up to 24 hours)	Blood samples will be collected to determine the C24 of MK-6916.
Plasma Concentration at 12 Hours (C12) of MK-6916	Predose and at designated time points (up to 12 hours)	Blood samples will be collected to determine the C12 of MK-6916.
Maximum Plasma Concentration (Cmax) of MK-6916	Predose and at designated time points (up to 8 weeks)	Blood samples will be collected to determine the Cmax of MK-6916.
Time to Maximum Plasma Concentration (Tmax) of MK-6916	Predose and at designated time points (up to 8 weeks)	Blood samples will be collected to determine the Tmax of MK-6916.
Apparent Clearance (CL/F) of MK-6916	Predose and at designated time points (up to 8 weeks)	Blood samples will be collected to determine the CL/F of MK-6916.
Apparent Volume of Distribution (Vz/F) of MK-6916	Predose and at designated time points (up to 8 weeks)	Blood samples will be collected to determine the Vz/F of MK-6916.
Apparent Terminal Half-life (t1/2) of MK-6916	Predose and at designated time points (up to 8 weeks)	Blood samples will be collected to determine the t1/2 of MK-6916.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 8 weeks	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. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 8 weeks	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. The number of participants who discontinue study treatment due to an AE will be reported.

Trial Locations

Locations (1)

Fortrea CRU, Madison ( Site 0001); 🇺🇸 Madison, Wisconsin, United States