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A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

JNJ-56021927

About this trial

This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic Impairment, JNJ-56021927

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JNJ-56021927

Arm Description

Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of JNJ-56021927

The Cmax is the maximum observed plasma concentration of JNJ-56021927.

Maximum Plasma Concentration Corrected for Unbound Fraction (Cmax_unb) of JNJ-56021927

The Cmax_unb is the maximum observed plasma concentration corrected for unbound fraction of JNJ-56021927.

Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-56021927

The Tmax is the time to reach the maximum observed plasma concentration of JNJ-56021927.

Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-56021927

The AUC(0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.

Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC[0-168]) Post Dose of JNJ-56021927

The AUC(0-168hrs) is the area under the plasma concentration-time curve from 0 to 168 hours post dosing.

Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of JNJ-56021927

The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.

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

The AUC(last_unb) corrected for unbound fraction is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.

Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-56021927

The AUC (0-infinity) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.

Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time Corrected for Unbound Fraction (AUC[infinity_unb]) Post Dose of JNJ-56021927

The AUC(infinity_unb) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time corrected for unbound fraction, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.

Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])

The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].

Terminal Half-life (t[1/2]) of JNJ-56021927

Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).

Elimination Rate Constant (Lambda [z]) of JNJ-56021927

The Lambda (z) determined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927

Time to last measurable plasma concentration is evaluated.

Total Apparent Clearance (CL/F) of JNJ-56021927

The CL/F is defined as Dose/AUC (0-infinity).

Apparent Volume of Distribution (Vd/F) of JNJ-56021927

The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].

Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)

The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.

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])

The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).

Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])

The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).

Secondary Outcome Measures

Number of Participants with Adverse Events (AEs) and Serious AEs

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Full Information

NCT ID

NCT02524717

First Posted

August 13, 2015

Last Updated

May 17, 2019

Sponsor

Aragon Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02524717

Brief Title

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

August 13, 2015 (Actual)

Primary Completion Date

February 9, 2017 (Actual)

Study Completion Date

February 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aragon Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

Hepatic Impairment, JNJ-56021927

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JNJ-56021927

Arm Type

Experimental

Arm Description

Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.

Intervention Type

Drug

Intervention Name(s)

JNJ-56021927

Intervention Description

Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.

Primary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax) of JNJ-56021927

Description

The Cmax is the maximum observed plasma concentration of JNJ-56021927.

Time Frame