Hepatic Impairment, Healthy Participants
Conditions
Brief summary
Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the Cmax of opevesostat. |
| Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat | At designated timepoints (up to approximately 24 hours post-dose) | Plasma samples will be collected to determine the AUC0-24 of opevesostat. |
| Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the AUC0-inf of opevesostat. |
| Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the AUC0-last of opevesostat. |
| Time to Maximum Concentration (Tmax) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the Tmax of opevesostat. |
| Apparent Terminal Half-life (t1/2) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the t1/2 of opevesostat. |
| Apparent Clearance (CL/F) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the CL/F of opevesostat. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat | At designated timepoints (up to approximately 96 hours post-dose) | Plasma samples will be collected to determine the Vz/F of opevesostat. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 2 weeks | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Number of Participants Who Discontinue Study Due to an AE | Up to approximately 2 weeks | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed