The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the blood and cerebrospinal fluid of healthy adult volunteers following administration of a single dose of JNJ-39393406.
This is a single-centre, double-blind (neither physician nor patient knows the name of the assigned treatment), single dose study of JNJ-39393406 or placebo (a treatment identical in appearance to JNJ-39393406 but does not contain active drug) in healthy adult volunteers. The study consists of an eligibility screening examination (between 21 and 2 days prior to dose administration), a double-blind treatment period, and a follow-up examination (minimally 7 and maximally 14 days after the dose administration). For each volunteer, the maximal study duration will not exceed 6 weeks. JNJ-39393406 or placebo will be administered as a single 200-mg dose on Day 1 as a liquid nanosuspension (a formulation used to improve the solubility of the drug) with 240 mL (approximately 8 ounces or 1 cup) noncarbonated water between 8:00 AM and 10:30 AM after a standard breakfast has been consumed (following a fast \[not eating food\] of at least 10 hours). Volunteers will then fast until approximately 4 hours after taking JNJ-3939406 or placebo after which lunch will be served.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
12
Type= exact number, Unit= mg, Number= 200, Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.
Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.
Plasma concentration of JNJ39393406
Time frame: At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose
Cerebral spinal fluid (CSF) concentration of JNJ39393406
Time frame: At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose
Incidence of adverse events as a measure of safety and tolerability
Time frame: Approximately 6 weeks
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