Apalutamide for Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is studying how a prostate cancer medication, apalutamide, is processed in the bodies of people with severe liver problems compared to those with normal liver function. The goal is to understand any differences in how the drug is absorbed, distributed, metabolized, and excreted between these two groups. Apalutamide is a next-generation androgen receptor inhibitor approved for treatment of subjects with high-risk, non-metastatic, castration-resistant prostate cancer (NM-CRPC).
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications, but you cannot use thyroid hormone replacement therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use thyroid hormone replacement therapy.
What safety data exists for Apalutamide (Erleada) in liver disease treatment?
Is the drug Apalutamide a promising treatment for liver disease?
What data supports the idea that Apalutamide for Liver Disease is an effective drug?
The available research does not provide any data on the effectiveness of Apalutamide for Liver Disease. Instead, it discusses other treatments for liver conditions, such as fenofibrate for primary biliary cirrhosis and combinations of ursodeoxycholic acid with other drugs for non-alcoholic fatty liver disease. There is no mention of Apalutamide being used for liver disease in the provided studies.7891112
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with severe liver disease (Child-Pugh score 10-15) and normal kidney function, as well as healthy individuals with normal liver and kidney function. Those with severe mental impairment, thyroid issues, sexual dysfunction affecting men's health or active hepatitis are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of apalutamide on Day 1 under fasted conditions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Apalutamide
Apalutamide is already approved in United States, European Union for the following indications:
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University