A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: Prednisone; Drug: Opevesostat; Drug: Fludrocortisone acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07548606

MK-5684-017 (Other Identifier)

5684-017

Details and patient eligibility

About

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 itraconazole.

Enrollment: 14 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

• Has a body mass index ≥18.0 and ≤32.0 kg/m^2
• Is medically healthy with no clinically significant medical history

Exclusion criteria

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

• Has a 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 heart block; clinically significant sick sinus syndrome; any systemic fungal infection; chronic infection; glaucoma; hypothyroidism; stomach ulcer; ocular herpes simplex; ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)
• Has a history of cancer (malignancy)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Opevesostat Period 1

Experimental group

Description:

On Day 1, a single dose of opevesostat will be administered under fed conditions. A single dose of steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.

Treatment:

Drug: Fludrocortisone acetate

Drug: Opevesostat

Drug: Prednisone

Opevesostat Period 2

Experimental group

Description:

There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, itraconazole will be administered once daily (QD) for 9 consecutive days with a single dose of opevesostat coadministered on Day 4 under fed conditions. Steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 4 through 6, approximately 4.5 hours after opevesostat and/or itraconazole dosing.

Treatment:

Drug: Fludrocortisone acetate

Drug: Opevesostat

Drug: Prednisone

Drug: Itraconazole