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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 19 Years and 55 Years
Eligible Sex
Male
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Opevesostat Period 1 		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.
  • Drug: Opevesostat
    Administered via oral film-coated tablet
    Other names:
    • MK-5684
    • ODM-208
  • Drug: Prednisone
    Administered via oral tablet
  • Drug: Fludrocortisone acetate
    Administered via oral tablet
Experimental
Opevesostat Period 2 		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.
  • Drug: Opevesostat
    Administered via oral film-coated tablet
    Other names:
    • MK-5684
    • ODM-208
  • Drug: Prednisone
    Administered via oral tablet
  • Drug: Fludrocortisone acetate
    Administered via oral tablet
  • Drug: Itraconazole
    Administered via oral capsule

Recruiting Locations

Celerion, Inc. ( Site 0001)
Lincoln, Nebraska 68502
Contact:
Study Coordinator
888-577-8839

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com