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

NCT ID: NCT06633419

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2025-05-13

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Opevesostat Period 1

On Day 1 a single dose of opevesostat will be administered under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.

Group Type: EXPERIMENTAL

Opevesostat

Intervention Type: DRUG

Administered via oral tablet per dosing regimen.

Prednisone

Intervention Type: DRUG

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

Fludrocortisone acetate

Intervention Type: DRUG

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

Opevesostat Period 2

There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2. In Period 2, carbamazepine will be administered twice daily (BID) for 17 consecutive days with a single dose of opevesostat coadministered on the morning of Day 14 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions on Day 14, approximately 4.5 hours after opevesostat and/or carbamazepine dosing.

Group Type: EXPERIMENTAL

Opevesostat

Intervention Type: DRUG

Administered via oral tablet per dosing regimen.

Prednisone

Intervention Type: DRUG

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

Fludrocortisone acetate

Intervention Type: DRUG

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

Carbamazepine

Intervention Type: DRUG

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

Interventions

Opevesostat

Administered via oral tablet per dosing regimen.

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

Fludrocortisone acetate

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

Intervention Type: DRUG

Carbamazepine

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

Intervention Type: DRUG

Other Intervention Names

MK-5684; ODM-208; RAYOS®; STERAPRED®; DELTASONE®; FLORINEF®; TEGRETOL®

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Celerion ( Site 0001)

Tempe, Arizona, United States

Countries

United States

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-5684-012

Identifier Type: OTHER

Identifier Source: secondary_id

5684-012

Identifier Type: -

Identifier Source: org_study_id