A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib

Hepatic Impairment Clinical Trial

Official title:

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03587363
• Other study ID #: CR108483
• Secondary ID: 2018-001104-1142
• Status: Terminated
• Phase: Phase 1
• Start date: December 6, 2018
• Est. completion date: December 22, 2020

Study information

• Verified date: March 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Man or woman must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1

• If a woman (a) must not be of childbearing potential postmenopausal or surgically sterile (b) must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the study drug administration

• If a woman who is considered surgically sterile but not postmenopausal, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening (exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)

• If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the study drug administration

• Participants with hepatic impairment must meet the Child-pug classification for mild, moderate or severe hepatic impairment and must have stable hepatic function

Exclusion Criteria:

• History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration

• Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc), with the exception of hepatic impairment

• History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before screening or positive test result(s) for drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, hallucinogens, and benzodiazepines) at screening and on Day -1

• Known allergy to the study drug or any of the excipients of the formulation (Physical Description of Study Drug[s], for a list of excipients)

• Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before study drug administration or intention to donate blood or blood products during the study

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Erdafitinib
Participants will receive 6 mg (2*3 mg tablet) erdafitinib as a single oral dose on Day 1. Participants in Cohort 4 may receive a lower dose if warranted by preliminary safety and PK data from Cohorts 2 and 3.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel
Germany	APEX GmbH	Munchen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax is the maximum observed plasma concentration.	Up to 21 days
Primary	Time to Reach the Maximum Observed Plasma Concentration (Tmax)	Tmax is the time to reach maximum observed plasma concentration.	Up to 21 days
Primary	Area Under Plasma Concentration-Time Curve (AUC)	AUC is area under plasma concentration-time curve.	Up to 21 days
Primary	Terminal Elimination Half-life (t1/2term, Lambda)	t1/2term, Lambda is elimination half-life associated with the terminal slope (Lambda[Z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda(Z).	Up to 21 days
Primary	Total Plasma Clearance (CL/F)	CL/F is total plasma clearance of drug after extravascular administration, uncorrected for absolute bioavailability (BA), calculated as Dose/AUC (0-infinity).	Up to 21 days
Primary	Apparent Volume of Distribution (Vd/F)	Vd/F is apparent volume of distribution after extravascular administration, uncorrected for absolute BA.	Up to 21 days
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.	Approximately 50 days

External Links

•   To learn how to participate in this trial please click here.