Clinical trial NCT02524717: A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function
Official title: A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Hepatic Impairment
JNJ-56021927
Lead sponsor: Aragon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-17
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.

Detailed description: This is an open-label (all people know the identity of the intervention), single-dose, single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of participation in the study for each participant is approximately 78 Days. Primarily the pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during Screening and those measured within 24 hours prior to study drug administration
* Sign an informed consent document indicating that the participant understands the purpose of and procedures required for the study and are willing to participate in the study. Participants must not have hepatic encephalopathy greater than or equal to (\>=) Grade 3 where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
* Willing and able to adhere to the prohibitions and restrictions as specified in the protocol
* If a man is sexually active with a woman of childbearing potential and has not had a vasectomy, he must agree to use an adequate contraception method as deemed appropriate by the Investigator, always use a condom during sexual intercourse, and agree to not donate sperm during the study and for 3 months after receiving the study drug
* Body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)\^2 (inclusive), and body weight not less than 50 kg
* The participant must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); the investigator will determine hepatic impairment

Exclusion Criteria:

* Screening thyroid-stimulating hormone (TSH) level greater than (\>) Upper Limit of Normal (ULN), or participants with known history of thyroid disorders
* Participant who is on thyroid replacement therapy
* History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for drugs of abuse (that is, opiates, barbiturates, benzodiazepines, cocaine, cannabinoids, and amphetamines) at Screening or Day -1. A positive test for participants with prescriptions for drugs that may interfere with the drug screen (that is, opiates and benzodiazepines) may be allowed
* Known allergy to the study drug or any of the excipients of the formulation
* Intention to donate blood or blood products during the study or for 3 months after the administration of the study drug
* A man who plans to father a child while enrolled in the study or for 3 months after receiving the study drug
* Known history of seizure or condition that may predispose to seizure or on medication that lowers seizure threshold
* History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
* Gall bladder (example, cholecystitis and cholelithiasis) or biliary tract disease
* Clinically significant renal laboratory findings including serum creatinine level greater than (\>) 1.5 times ULN
* Inability to fast for 12 hours
* History of or current clinically significant medical illness
* Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Maximum Plasma Concentration Corrected for Unbound Fraction (Cmax_unb) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC[0-168]) Post Dose of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration Corrected for Unbound Fraction (AUC[last_unb]) Post Dose of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time Corrected for Unbound Fraction (AUC[infinity_unb]) Post Dose of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Terminal Half-life (t[1/2]) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Elimination Rate Constant (Lambda [z]) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Total Apparent Clearance (CL/F) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Apparent Volume of Distribution (Vd/F) of JNJ-56021927
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])
timeFrame: Pre-dose up to 1344 hours post-dose
measure: Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])
timeFrame: Pre-dose up to 1344 hours post-dose
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Screening up to follow-up (56 days after dose administration)
Other outcomes:
Locations:
city: Knoxville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: