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

NCT ID: NCT06703463

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2024-02-02

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MK-1167 Period 1

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

Group Type EXPERIMENTAL

MK-1167

Intervention Type DRUG

Administered via oral capsule per dosing regimen.

MK-1167 Period 2

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.

Group Type EXPERIMENTAL

MK-1167

Intervention Type DRUG

Administered via oral capsule per dosing regimen.

Diltiazem

Intervention Type DRUG

Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.

Interventions

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MK-1167

Administered via oral capsule per dosing regimen.

Intervention Type DRUG

Diltiazem

Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Celerion (Site 0002)

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-1167-006

Identifier Type: OTHER

Identifier Source: secondary_id

1167-006

Identifier Type: -

Identifier Source: org_study_id

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