A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Diltiazem; Drug: MK-1167

Study type: Interventional

Funder types: Industry

Identifiers

NCT06703463

1167-006

MK-1167-006 (Other Identifier)

Details and patient eligibility

About

The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem.

Enrollment: 16 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
• Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
• Able to swallow multiple capsules
• In good health

Exclusion criteria

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

• History or presence of second- or third-degree atrioventricular heart block (except in participants with a functional artificial pacemaker)
• History or presence of clinically significant sick sinus syndrome
• History of cancer (malignancy) within the past 5 years
• Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

MK-1167 Period 1

Experimental group

Description:

On Day 1 a single dose of MK-1167 will be administered.

Treatment:

Drug: MK-1167

MK-1167 Period 2

Experimental group

Description:

There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3.

Treatment:

Drug: MK-1167

Drug: Diltiazem