18 Participants Needed

Apalutamide for Liver Disease

Recruiting at 6 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

The provided research does not contain safety data for Apalutamide (Erleada) in the treatment of liver disease. The studies mentioned focus on other treatments such as sofosbuvir/velpatasvir for hepatitis C and rilpivirine, but none address Apalutamide or its safety profile in liver disease.12345

Is the drug Apalutamide a promising treatment for liver disease?

The information provided does not include any studies or evidence about Apalutamide being used for liver disease. Therefore, we cannot say if it is a promising treatment for liver disease based on the given data.678910

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?

JR

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

My kidney function is normal, with creatinine levels within the normal range.
My liver functions normally and I am in good health.
I have severe liver problems with a specific score.
See 2 more

Exclusion Criteria

Any participant with screening thyroid stimulating hormone (TSH) level > upper limit of normal (ULN)
I have normal liver function and may have been exposed to Hepatitis A, B, or C.
I have normal liver function but experience sexual dysfunction.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of apalutamide on Day 1 under fasted conditions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Apalutamide
Trial Overview The study tests how a single dose of Apalutamide is processed by the body in people with severe liver damage compared to those with healthy livers. It aims to understand differences in drug behavior due to liver health.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2: Participants with Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants with normal hepatic function will receive single oral dose of apalutamide on Day 1 under fasted condition.
Group II: Group 1: Participants with Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment will receive single oral dose of apalutamide on Day 1 under fasted condition.

Apalutamide is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Erleada for:
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Metastatic castration-sensitive prostate cancer (mCSPC)
🇪🇺
Approved in European Union as Erleada for:
  • 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

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study involving nine patients with asymptomatic primary biliary cirrhosis (aPBC) who did not fully respond to ursodeoxycholic acid (UDCA), fenofibrate treatment for twelve weeks significantly reduced serum levels of alkaline phosphatase and immunoglobulin M, indicating improved liver function and immune response.
Fenofibrate was well-tolerated with no adverse reactions reported, suggesting it is a safe addition to UDCA therapy for patients with aPBC, potentially enhancing treatment efficacy through its anti-inflammatory and immunomodulatory effects.
Fenofibrate for patients with asymptomatic primary biliary cirrhosis.Dohmen, K., Mizuta, T., Nakamuta, M., et al.[2021]
The combination of ursodeoxycholic acid (UDCA) with rosuvastatin (RSV) and ezetimibe (EZE) significantly reduced liver damage markers, collagen accumulation, and fibrosis in various NAFLD mouse models, indicating its potential efficacy in treating the disease.
This combination therapy not only decreased serum alanine aminotransferase (ALT) levels and apoptosis in liver cells but also improved cell survival, suggesting a promising new strategy for inhibiting the progression of non-alcoholic fatty liver disease.
Co-administration of ursodeoxycholic acid with rosuvastatin/ezetimibe in a non-alcoholic fatty liver disease model.Seo, SH., Lee, DH., Lee, YS., et al.[2022]
In a 72-week study involving 48 patients with nonalcoholic steatohepatitis (NASH), apararenone 10 mg/day demonstrated significant improvements in liver fibrosis markers compared to placebo, indicating its potential efficacy in treating this condition.
Apararenone was found to be safe and well-tolerated, with similar rates of adverse drug reactions as the placebo group, although it did cause a temporary increase in serum potassium levels that returned to baseline after treatment.
Efficacy and safety of apararenone (MT-3995) in patients with nonalcoholic steatohepatitis: A randomized controlled study.Okanoue, T., Sakamoto, M., Harada, K., et al.[2021]

Citations

Fenofibrate for patients with asymptomatic primary biliary cirrhosis. [2021]
Co-administration of ursodeoxycholic acid with rosuvastatin/ezetimibe in a non-alcoholic fatty liver disease model. [2022]
Efficacy and safety of apararenone (MT-3995) in patients with nonalcoholic steatohepatitis: A randomized controlled study. [2021]
Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study. [2023]
Gemcabene downregulates inflammatory, lipid-altering and cell-signaling genes in the STAM™ model of NASH. [2018]
The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis. [2023]
Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan. [2021]
Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). [2019]
[Safety profile of rilpivirine: general and neuropsychiatric tolerability, safety in patients with hepatitis B or C viruses, and lipid profile]. [2016]
Sofosbuvir Adverse Events Profile in a Subset of Pakistani Population. [2018]
Effect of pemafibrate on liver enzymes and shear wave velocity in non-alcoholic fatty liver disease patients. [2023]
Efficacy of 3 months of additional pioglitazone treatment in type 2 diabetes patients with alcoholic fatty liver disease. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security