Skip to main content
OpenTrials
Completed

NCT Number: NCT06633419

A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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
  • 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

Treatment and study plan

Opevesostat

Drug

Administered via oral tablet per dosing regimen.

Other names: MK-5684, ODM-208

Prednisone

Drug

Administered at a dose of 5 mg or 10 mg dependent on HRT dosing regimen via oral tablets.

Other names: RAYOS®, STERAPRED®, DELTASONE®

fludrocortisone acetate

Drug

Administered at a dose of 0.05 mg or 0.1 mg dependent on HRT dosing regimen via oral tablets.

Other names: FLORINEF®

carbamazepine

Drug

Administered at a dose of 100 mg, 200 mg, or 300 mg BID dependent on dosing regimen via oral capsule (extended-release).

Other names: TEGRETOL®

Primary outcomes

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

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    AUC0-inf of opevesostat in plasma will be determined.

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

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    AUC0-last of opevesostat in plasma will be determined.

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

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

    AUC0-24 of opevesostat in plasma will be determined.

  4. Maximum concentration (Cmax) of opevesostat in plasma

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    Cmax of opevesostat in plasma will be determined.

  5. Time to Maximum concentration (Tmax) of opevesostat in plasma

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    Tmax of opevesostat in plasma will be determined.

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

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    t1/2 of opevesostat in plasma will be determined.

  7. Apparent Clearance (CL/F) of opevesostat in plasma

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    CL/F of opevesostat in plasma will be determined.

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

    Time frame: Predose, and at designated timepoints up to 96 hours post-dose

    Vz/F of opevesostat in plasma will be determined.

Secondary outcomes

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

    Time frame: Up to approximately 49 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. The number of participants who experience an AE will be determined.

  2. Number of participants who discontinue study intervention due to an AE

    Time frame: Up to approximately 49 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. The number of participants who discontinue from the study due to an AE 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 Effects of Multiple Doses of Carbamazepine on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
May 25, 2025

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.