The purpose of this study is to compare the pharmacokinetic profile of a single dose of two solid dosage formulations relative to a reference formulation (solution in polyethylene glycol-400 \[PEG-400\]) of JNJ-64140284 in healthy male participants under fasting condition and to assess the effect of food on the bioavailability of two solid dosage formulations of JNJ-64140284.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1
Participants will receive JNJ-64140284 orally.
Clinical Pharmacology Unit
Merksem, Belgium
Peak Plasma Concentration (Cmax) of JNJ-64140284
Cmax is defined as the peak plasma concentration of JNJ-64140284.
Time frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
Area Under The Plasma Concentration-time Curve From 0 to t Hours Postdosing (AUC[0-t]) of JNJ-64140284
AUC(0-t) is defined as the area under the plasma concentration-time curve from 0 to t hours postdosing of JNJ-64140284 (time t is the time of the last quantifiable concentration \[Clast\]).
Time frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of JNJ-64140284
AUC(0-inf) is defined as the area under plasma concentration-time from time 0 to infinity extrapolated to infinity of JNJ-64140284.
Time frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
Relative Bioavailability (F[rel]) of JNJ-64140284
F(rel) is defined as the relative bio-availability of JNJ-64140284 calculated as individual Cmax and AUC treatment ratio's (for the comparison of the capsule \[solid 5 micro-meter (mcm) or solid 31 mcm\] to the solution and for the comparison of fed versus fasted for the capsule \[both for solid 5 mcm and solid 31 mcm\]).
Time frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 13 weeks
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