The purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2.
Participants will receive JNJ-54416076 Tablet formulation 1 (5\*5 mg Tablets \[25 mg total\]) under fasted and fed condition in Part 1.
Participants will receive JNJ-54416076 Tablet formulation 2 (5\*5 mg Tablets \[25 mg total\]) under fasted and fed condition in Part 2.
Unnamed facility
Tempe, Arizona, United States
Maximum Observed Analyte Concentration (Cmax)
Cmax is the maximum observed analyte concentration.
Time frame: Predose up to Day 4
Time to Reach Maximum Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time frame: Predose up to Day 4
Area Under Concentration Curve from time zero to the last quantifiable (AUC [0-last])
Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear trapezoidal summation.
Time frame: Predose up to Day 4
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(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Time frame: Predose up to Day 4
Apparent Terminal Elimination Half-life (t1/2term)
The elimination halflife (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda\[z\]).
Time frame: Predose up to Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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Time frame: 5 to 7 days after discharge (Follow-Up Phase )