Clinical trial NCT06554639: A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
measure: Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
measure: Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 24 hours post-dose
measure: Maximum concentration (Cmax) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
measure: Time to Maximum concentration (Tmax) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
measure: Apparent terminal half-life (t1/2) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
measure: Apparent Clearance (CL/F) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma
timeFrame: Predose, and at designated timepoints up to 120 hours post-dose
Secondary outcomes:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 39 days
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 39 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: