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

November 21, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-1167 in Healthy Adult Participants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion (Site 0002)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-1167 Period 1
On Day 1 a single dose of MK-1167 will be administered.
Drug: MK-1167
Administered via oral capsule per dosing regimen.
Experimental: 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.
Drug: MK-1167
Administered via oral capsule per dosing regimen.
Drug: Diltiazem
Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to approximately 99 days
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.
Up to approximately 99 days
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to approximately 85 days
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.
Up to approximately 85 days
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
AUC0-inf of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
AUC0-last of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose
Maximum concentration (Cmax) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
Cmax of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose
Concentration at hour 24 (C24) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 24 hours post-dose
C24 of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 24 hours post-dose
Time to maximum concentration (Tmax) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
Tmax of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose
Apparent terminal half-life (t1/2) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
t1/2 of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose
Apparent clearance (CL/F) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
CL/F of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma
Time Frame: Predose, and at designated timepoints up to 50 days post-dose
Vz/F of MK-1167 in plasma will be determined.
Predose, and at designated timepoints up to 50 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

February 2, 2024

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1167-006
  • MK-1167-006 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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