A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy; Pain

Treatments: Drug: Diltiazem; Drug: MK-4318

Study type: Interventional

Funder types: Industry

Identifiers

NCT06692647

4318-003

MK-4318-003 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to learn what happens to MK-4318 in a person's body over time. Researchers will compare what happens to levels of MK-4318 in people's blood when it is taken with and without diltiazem. Researchers also want to learn about the safety of MK-4318 taken with and without diltiazem and if people tolerate them.

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

• Is in good health based on medical history and physical examination
• Has a body mass index >18 and ≤32 kg/m^2, inclusive

Exclusion Criteria

The main 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 (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cardiac arrythmia or recurrent unexplained syncopal events

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

MK-4318 Plus Diltiazem

Experimental group

Description:

Participants will move sequentially through 2 Periods. In Period 1, participants receive MK-4318 orally. In Period 2, participants receive MK-4318 orally plus diltiazem orally.

Treatment:

Drug: MK-4318

Drug: Diltiazem