Evaluating a new treatment for prostate cancer in men with liver impairment
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment
PHASE1 · Merck Sharp & Dohme LLC · NCT06860243
This study is testing a new prostate cancer medication called opevesostat in men with liver issues to see how it works in their bodies compared to healthy men.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06860243 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics of a new medication called opevesostat in male participants, specifically focusing on those with moderate hepatic impairment compared to healthy individuals. The goal is to understand how the drug behaves in the body over time, which is crucial for determining its safety and efficacy. Participants will receive opevesostat along with other medications, and their responses will be monitored closely. This phase 1 study aims to gather essential data that could inform future treatment options for prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include male participants with moderate hepatic impairment and a stable diagnosis of chronic liver insufficiency.
Not a fit: Patients with a history of cancer, certain viral infections, or significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for prostate cancer patients with liver impairment.
How similar studies have performed: While this approach is novel in evaluating opevesostat specifically in patients with liver impairment, similar pharmacokinetic studies have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
The main inclusion criteria include but are not limited to the following: * All participants: * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing * Has body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 * Participants with moderate hepatic impairment: * Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology The main exclusion criteria include but are not limited to the following: * All participants: * Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome) * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) * Participants with moderate hepatic impairment * Has unstable electrolyte abnormalities or electrolyte abnormalities that are considered difficult to manage for participants with hepatic impairment * Has a history of liver or other solid organ transplantation
Where this trial is running
Miami, Florida and 1 other locations
- Clinical Pharmacology of Miami ( Site 0002) — Miami, Florida, United States (RECRUITING)
- Texas Liver Institute ( Site 0001) — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatic Impairment, Healthy Participants