A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Metastatic Prostate Cancer

Treatments: Drug: Fludrocortisone; Drug: [¹⁴C]Opevesostat; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06566989

MK-5684-008 (Other Identifier)

5684-008

1010197 (Registry Identifier)

Details and patient eligibility

About

This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability.

Enrollment: 8 patients

Sex: Male

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is a healthy male according to the assessment of the investigator
• Has a body mass index of 18.0 to 32.0 kg/m2
• Has regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)

Exclusion criteria

• Has the presence or history of clinically significant allergy requiring treatment
• Has a history of adrenal insufficiency
• Has veins not suitable for multiple venipunctures/cannulation
• Has previously taken part in more than 3 radiolabeled drug studies in the last 12 months
• Has donated blood or plasma within the previous 3 months or lost greater than 400 mL of blood

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

[¹⁴C]Opevesostat

Experimental group

Description:

On Day 1, participants receive a single dose of \[¹⁴C\]opevesostat as an oral solution. Participants then receive single doses of 5.0 mg prednisone and 0.05 mg fludrocortisone tablets 4 hours later as hormone replacement therapy.

Treatment:

Drug: Prednisone

Drug: [¹⁴C]Opevesostat

Drug: Fludrocortisone