NCT06566989CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 20 Aug 2024
- Start date
- 19 Sept 2024
- Primary completion date
- 17 Oct 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Prostate cancer
- NCT number
- NCT06566989
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 19 Sept 2024 to the primary completion date, 17 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Has the presence or history of clinically significant allergy requiring treatment
- Has a history of adrenal insufficiency
Other
- Has veins not suitable for multiple venipunctures/cannulation
Who the study is looking for
- 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)
Age in the registry: 30 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Quotient Sciences ( Site 0001) Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.