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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2024-10-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[¹⁴C]Opevesostat

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.

Group Type EXPERIMENTAL

[¹⁴C]Opevesostat

Intervention Type DRUG

Oral solution

Prednisone

Intervention Type DRUG

Tablet

Fludrocortisone

Intervention Type DRUG

Tablet

Interventions

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[¹⁴C]Opevesostat

Oral solution

Intervention Type DRUG

Prednisone

Tablet

Intervention Type DRUG

Fludrocortisone

Tablet

Intervention Type DRUG

Other Intervention Names

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MK-5684 RAYOS® STERAPRED® DELTASONE® FLORINEF®

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes