The purpose of this study is to assess the relative bioavailability of 1 to 3 concept formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678 when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Participants will receive JNJ-53718678 under fed or fasted conditions.
Unnamed facility
Merksem, Belgium
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
The Cmax is the maximum observed plasma concentration.
Time frame: Up to 72 hour of Post-dose
Area Under the Plasma ConcentrationTime Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0last]) of JNJ-53718678
The AUC (0-last) is the area under the plasma concentration time curve from time 0 to the time of the last measurable non-below quantification limit concentration, calculated by liner-linear trapezoidal summation.
Time frame: Up to 72 hour of Post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-53718678
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(last) and C(last)/lambda(z); wherein AUC(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.
Time frame: Up to 72 hour of Post-dose
Relative Bioavailability of JNJ-53718678
The relative bioavailability based on Cmax, AUC(0last), and AUC(0-inf) will be estimated as 100\*Test/Reference, where Test is defined as the pharmacokinetic parameters of oral JNJ-53718678 and Reference is defined as currently existing oral solution G024.
Time frame: Up to 72 hour of Post-dose
Effect of Food on the Bioavailabilty of JNJ-53718678
The effect of food will be evaluated by comparing the pharmacokinetics of JNJ-53718678 under fed conditions with the currently existing oral solution under fasted conditions.
Time frame: Up to 72 hour of Post-dose
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to 35 days after last study drug intake
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