JNJ-56021927
DrugParticipants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
NCT Number: NCT02524717
The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.
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Notify Me18 year–80 year
Male
Interventional
Phase 1
Knoxville, Tennessee, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
Time frame: Pre-dose up to 1344 hours post-dose
The Cmax is the maximum observed plasma concentration of JNJ-56021927.
Time frame: Pre-dose up to 1344 hours post-dose
The Cmax_unb is the maximum observed plasma concentration corrected for unbound fraction of JNJ-56021927.
Time frame: Pre-dose up to 1344 hours post-dose
The Tmax is the time to reach the maximum observed plasma concentration of JNJ-56021927.
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(0-168hrs) is the area under the plasma concentration-time curve from 0 to 168 hours post dosing.
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Time frame: Pre-dose up to 1344 hours post-dose
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.
Time frame: Pre-dose up to 1344 hours post-dose
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.
Time frame: Pre-dose up to 1344 hours post-dose
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.
Time frame: Pre-dose up to 1344 hours post-dose
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].
Time frame: Pre-dose up to 1344 hours post-dose
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Time frame: Pre-dose up to 1344 hours post-dose
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 frame: Pre-dose up to 1344 hours post-dose
Time to last measurable plasma concentration is evaluated.
Time frame: Pre-dose up to 1344 hours post-dose
The CL/F is defined as Dose/AUC (0-infinity).
Time frame: Pre-dose up to 1344 hours post-dose
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Time frame: Pre-dose up to 1344 hours post-dose
The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.
Time frame: Pre-dose up to 1344 hours post-dose
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]).
Time frame: Pre-dose up to 1344 hours post-dose
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]).
Time frame: Screening up to follow-up (56 days after dose administration)
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.
Aragon Pharmaceuticals, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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