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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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