A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: JNJ-39393406

Study type

Interventional

Funder types

Industry

Identifiers

NCT01556217

2010-022062-26 (EudraCT Number)

39393406ALZ1004 (Other Identifier)

CR017404

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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