Clinical trial NCT06566989: A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)
Official title: An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Prostate Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2024-08-22
Enrollment: 8
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat
timeFrame: Predose and at designated time points (up to 8 days)
measure: Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat
timeFrame: Predose and at designated time points (up to 8 days)
measure: Cumulative percentage of total radioactivity excreted in urine (Cumfeu) after administration of single-dose [¹⁴C]Opevesostat
timeFrame: Predose and at designated time points (up to 8 days)
measure: Cumulative percentage of total radioactivity excreted in feces (Cumfef) after administration of single-dose [¹⁴C]Opevesostat
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Opevesostat Pharmacokinetics: Time of maximum observed concentration (Tmax)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Opevesostat Pharmacokinetics: Terminal elimination half-life (t1/2)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Total Radioactivity Pharmacokinetics: Maximum observed concentration (Cmax)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Total Radioactivity Pharmacokinetics: Time of maximum observed concentration (Tmax)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Plasma Total Radioactivity Pharmacokinetics: Terminal elimination half-life (t1/2)
timeFrame: Predose and at designated time points (up to 8 days)
measure: Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
timeFrame: Predose and at designated time points (up to 8 days)
measure: Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
timeFrame: Predose and at designated time points (up to 8 days)
measure: Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
timeFrame: Predose and at designated time points (up to 8 days)
Secondary outcomes:
measure: Number of Participants with One or More Adverse Events (AEs)
timeFrame: Up to approximately 8 days
measure: Number of Participants who Discontinue from the Study Due to an AE
timeFrame: Up to approximately 8 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences ( Site 0001)
state: Nottinghamshire
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: