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Completed

NCT Number: NCT06703463

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

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.

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0002)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1167

Drug

Administered via oral capsule per dosing regimen.

Diltiazem

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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