A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||A Double-blind, Placebo-controlled, Single Dose, Pharmacokinetic Study to Characterize the Central Brain Penetrance of JNJ-39393406 Using Cerebrospinal Fluid in Healthy Male and Female Subjects|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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.
|Placebo Comparator: Placebo||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556217
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|