Clinical trial · Interventional
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
NCT06566989CI-TRIAL-00081878completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [¹⁴C]Opevesostat | Drug | — | UNRESOLVED |
| Fludrocortisone | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [¹⁴C]Opevesostat
- 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.
- interventionNames
- Drug: [¹⁴C]Opevesostat
- Drug: Prednisone
- Drug: Fludrocortisone
Primary outcomes (17)
- 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)
- description
- Urine samples will be collected at pre-specified timepoints and used to determine CumAeu.
- measure
- Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.