Clinical trial NCT06633419: A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)
Official title: A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Carbamazepine on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 14
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: BASIC_SCIENCE

Brief summary: Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.

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


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
  * Gallstones, hepatitis disease, or hepatic porphyrias
  * Psychosis
  * Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events
  * Second- or third-degree atrioventricular heart block
  * Clinically significant sick sinus syndrome
  * Recurrent seizures, increased risk for seizures, or myasthenia gravis
  * Clinically significant hematologic disorders/blood dyscrasias, including adverse hematologic reactions to any drugs or experimental therapies
  * Any systemic fungal infection
  * Chronic infection
  * Glaucoma
  * Hypothyroidism
  * Unexplained electrolyte abnormalities, current hyponatremia, diuretic use, or syndrome of inappropriate antidiuretic hormone secretion (siADH)
  * Severe dermatologic reaction
  * Stomach ulcer
* 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 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 opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
measure: Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
measure: Area under the concentration versus time curve from 0 to hour 24 (AUC0-24) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 24 hours post-dose
measure: Maximum concentration (Cmax) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
measure: Time to Maximum concentration (Tmax) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
measure: Apparent terminal half-life (t1/2) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
measure: Apparent Clearance (CL/F) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of opevesostat in plasma
timeFrame: Predose, and at designated timepoints up to 96 hours post-dose
Secondary outcomes:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 49 days
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 49 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: