The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60 milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male Japanese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
JNJ-56021927 60 mg oral tablet.
JNJ-56021927 120 mg as 2 tablets of 60 mg.
JNJ-56021927 240 mg as 4 tablets of 60 mg.
Unnamed facility
Kumamoto, Japan
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) will be assessed.
Time frame: Predose, Up to Day 57
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed.
Time frame: Predose, Up to Day 57
Area Under Concentration from time zero to the last quantifiable AUC (0-last)
AUC from time zero to the last quantifiable concentration will be assessed.
Time frame: Predose, Up to Day 57
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. AUC (0-infinity) will be assessed.
Time frame: Predose, Up to Day 57
Time to Last Quantifiable Plasma Concentration (Tlast)
The Tlast, time to last observed quantifiable plasma concentration will be assessed.
Time frame: Predose, Up to Day 57
Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext)
Percentage of area under the plasma concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC,ext) is calculated as (AUC \[0-infinity\] minus AUC \[0-last\])/ AUC \[0-infinity\])\*100.
Time frame: Predose, Up to Day 57
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Apparent Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F will be calculated as CL/F = Dose/AUC \[0-infinity\]
Time frame: Predose, Up to Day 57
Apparent Terminal Elimination Half-life (t1/2term)
Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (λz)
Time frame: Predose, Up to Day 57
Apparent Terminal Elimination Rate Constant (lambda z)
Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data
Time frame: Predose, Up to Day 57
Apparent Volume of Distribution (Vd/F)
Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (λz)\*AUC \[0-infinity\]
Time frame: Predose, Up to Day 57
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Metabolite to parent drug ratio for Cmax will be assessed.
Time frame: Predose, Up to Day 57
Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last])
Metabolite to parent drug ratio for AUC \[0-last\] will be assessed.
Time frame: Predose, Up to Day 57
Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity])
Metabolite to parent drug ratio for AUC \[0-infinity\] will be assessed.
Time frame: Predose, Up to Day 57
Area Under Curve from time of administration to 24 hours post dosing
AUC from time of administration to 24 hours post dosing will be assessed.
Time frame: Predose, Up to Day 57
Area Under Curve from time of administration to 168 hours post dosing
AUC from time of administration to 168 hours post dosing will be assessed.
Time frame: Predose, Up to Day 57
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 57