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

NCT ID: NCT01556217

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-11-30

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

JNJ-39393406

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

JNJ-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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Other Identifiers

39393406ALZ1004

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022062-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017404

Identifier Type: -

Identifier Source: org_study_id