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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR1018 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-56021927 | Experimental | Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-56021927 | Drug | Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-56021927 | The Cmax is the maximum observed plasma concentration of JNJ-56021927. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knoxville | Tennessee | United States | ||||
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| Label | URL |
|---|---|
| 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 | View source |
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| 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. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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]. | Pre-dose up to 1344 hours post-dose |
| 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). | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927 | Time to last measurable plasma concentration is evaluated. | Pre-dose up to 1344 hours post-dose |
| Total Apparent Clearance (CL/F) of JNJ-56021927 | The CL/F is defined as Dose/AUC (0-infinity). | Pre-dose up to 1344 hours post-dose |
| Apparent Volume of Distribution (Vd/F) of JNJ-56021927 | The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)]. | Pre-dose up to 1344 hours post-dose |
| 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. | Pre-dose up to 1344 hours post-dose |
| 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]). | Pre-dose up to 1344 hours post-dose |
| 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]). | Pre-dose up to 1344 hours post-dose |
| Screening up to follow-up (56 days after dose administration) |
| San Antonio |
| Texas |
| United States |