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Antiandrogen

Apalutamide for Liver Disease

Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with severe hepatic impairment must have a total Child-Pugh score of 10 to 15 inclusive, as determined by the investigator during screening and on Day -1 prior to study drug administration. Source documents to substantiate the clinical diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory results or clinical findings), and medical history will be reviewed and signed by the investigator
Participants with normal hepatic function must have serum creatinine within normal limits and Creatinine Clearance (CrCL) greater than (>) 60 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) as calculated per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 78 days
Awards & highlights

Study Summary

This trial will look at how well the body processes a new drug, apalutamide, in people with severely impaired liver function compared to those with normal liver function.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones from Apalutamide may include fatigue, high blood pressure, rash, diarrhea, weight loss and fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is severely impaired, with a Child-Pugh score between 10 to 15.
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My kidney function is normal, with creatinine levels within the normal range.
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My liver functions normally and I am in good health.
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My kidney function is good, with a filtration rate of at least 45 mL/min.
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I have severe liver problems with a specific score.
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My kidney function is good, with a filtration rate of at least 45 mL/min.
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My kidney function is normal, with creatinine levels within the normal range.
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I do not have severe liver-related brain issues that prevent me from understanding this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 78 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 78 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide
Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide
Peak Plasma Concentration (Cmax) of Apalutamide
Secondary outcome measures
Number of Participants with Adverse Event as a Measure of Safety and Tolerability

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
91%
Hot flashes
88%
Fatigue
62%
Anemia
47%
Hyperglycemia
41%
Dry skin
32%
Cholesterol high
29%
Rash
29%
Insomnia
26%
Dizziness
26%
TSH increased
26%
Hypertriglyceridemia
24%
Arthralgia
24%
Headache
21%
Lipase increase
21%
Memory impairment
15%
Hypertension
12%
AST increase
12%
Amylase increase
12%
White blood cell decrease
12%
Anxiety
12%
Dysgeusia
12%
Irritability
12%
Nausea
9%
ALT increase
9%
Alopecia
9%
Erectile dysfunction
9%
Hypothyrodism
6%
Paresthesia
6%
Bruising
6%
Weight loss
6%
Anorexia
6%
Cognitive disturbance
6%
Constipation
6%
HbA1c increased
6%
GERD
6%
Generalized Muscle Weakness
6%
Hypercalcemia
6%
Fall
6%
Lymphocyte count decrease
6%
Insulin increase
6%
LDH increase
6%
Vitamin D decrease
3%
Personality change
3%
Myalgia
3%
Syncope
3%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (LHRHa, Apalutamide)
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~1510

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,384,272 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,891 Total Patients Enrolled

Media Library

Apalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04154774 — Phase 1
Liver Disease Research Study Groups: Group 1: Participants with Severe Hepatic Impairment, Group 2: Participants with Normal Hepatic Function
Liver Disease Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT04154774 — Phase 1
Apalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154774 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial pioneering for its respective field?

"Research into the efficaciousness of apalutamide began in 2014, and was sponsored by Aragon Pharmaceuticals. Following a successful Phase 3 trial involving 982 participants, it received its drug approval. Nowadays, 44 studies utilizing apalutamide are being conducted around the world across 552 cities spread over 38 countries."

Answered by AI

Can I apply to be a participant in this trial?

"Patients who are afflicted with hepatic impairment and between the ages of 18 and 80 may be eligible to join this trial. In total, 16 individuals will receive admittance into the study."

Answered by AI

Can you provide a list of research trials which have tested Apalutamide's efficacy?

"Apalutamide was first tested in a clinical trial with the identifier NCT02257736 back in 2014. Since then, 18 further trials have been successfully completed and 44 are actively recruiting patients primarily from Orlando, Florida."

Answered by AI

What potential risks are associated with Apalutamide use?

"Our researchers at Power have assigned Apalutamide a score of 1 due to its Phase 1 trial status, which implies that the available data regarding safety and efficacy is limited."

Answered by AI

Are geriatric patients within the parameters of eligibility for this clinical trial?

"This clinical research has specific enrolment requirements, which states that prospective participants must be between 18 to 80 years old. There are 27 studies specifically for minors and 267 individual cases involving seniors."

Answered by AI

To what extent has the patient recruitment process been successful for this medical experiment?

"Affirmative. The relevant clinicaltrials.gov page suggests that this medical experiment is still searching for participants and was first uploaded on November 7th, 2019 with the last update being made on 22nd of November 2022. This trial seeks to enlist 16 individuals from two different sites."

Answered by AI

Is enrollment open for this trial?

"As per the clinicaltrials.gov page, recruitment for this trial is ongoing and was initially announced on November 7th 2019 with last update taking place on November 22nd 2022."

Answered by AI
~1 spots leftby May 2024