Skip to main content
OpenTrials
Completed

NCT Number: NCT06554639

A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)

Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer.

The purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, 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 tablets

Exclusion criteria

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

  • History or presence of any of the following:
  • Adrenal insufficiency
  • Hepatic or renal impairment
  • Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events
  • Second- or third-degree Atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker)
  • Clinically significant sick sinus syndrome
  • Presence of any systemic fungal infection
  • Chronic infection
  • Glaucoma
  • Hypothyroidism
  • Stomach ulcer
  • Ocular herpes simplex
  • Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
  • History of cancer (malignancy)
  • Unable to refrain from or anticipants the use of: 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-5684

Drug

Administered via oral tablet per dosing regimen.

Prednisone

Drug

Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets.

fludrocortisone acetate

Drug

Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets.

Diltiazem hydrocholoride

Drug

Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).

Primary outcomes

  1. Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    AUC0-inf of MK-5684 in plasma will be determined.

  2. Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    AUC0-last of MK-5684 in plasma will be determined.

  3. Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 24 hours post-dose

    AUC0-24 of MK-5684 in plasma will be determined.

  4. Maximum concentration (Cmax) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    Cmax of MK-5684 in plasma will be determined.

  5. Time to Maximum concentration (Tmax) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    Tmax of MK-5684 in plasma will be determined.

  6. Apparent terminal half-life (t1/2) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    t1/2 of MK-5684 in plasma will be determined.

  7. Apparent Clearance (CL/F) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    CL/F of MK-5684 in plasma will be determined.

  8. Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma

    Time frame: Predose, and at designated timepoints up to 120 hours post-dose

    Vz/F of MK-5684 in plasma will be determined.

Secondary outcomes

  1. Number of participants who experience one or more adverse events (AEs)

    Time frame: Up to approximately 39 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 39 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.

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 Effects of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Oct 15, 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.

Published trials that share one or more normalized conditions with this study.