Healthy Volunteers
Conditions
Keywords
Healthy volunteers, JNJ-39393406-aaa, Pharmacokinetics, Central brain penetrance, Cerebral spinal fluid
Brief summary
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.
Detailed description
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.
Interventions
DRUGJNJ-39393406
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.
DRUGPlacebo
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.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Female volunteers must be postmenopausal (for at least 12 months) * Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive * Healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12-lead ECG \[including QTcB interval duration \<450 msec\] performed at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable * Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel \[including liver enzymes\], hematology, or urinalysis are outside the normal reference ranges, the volunteer may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant
Exclusion criteria
* History of liver or renal insufficiency * significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Relevant history of or current neurological disease including any history of post dural puncture headache, lower back pain or scoliosis and/or major (lumbar) back surgery, spontaneous, prolonged or severe bleeding with unclear origin, epilepsy or fits or unexplained black-outs * History or family history of abnormal bleeding or of blood clotting or anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of JNJ39393406 | 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 | At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events as a measure of safety and tolerability | Approximately 6 weeks |
Outcome results
None listed