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

COMPLETEDPHASE1

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

An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants

NCT06566989•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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

Locations (1)

Quotient Sciences ( Site 0001)

Nottingham, Nottinghamshire, United Kingdom

Key Dates

Start Date

September 19, 2024

Primary Completion Date

October 17, 2024

Completion Date

October 17, 2024

Last Updated

October 23, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Prostate Cancer

Interventions

[¹⁴C]Opevesostat

DRUG

Prednisone

DRUG

Fludrocortisone

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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