Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01556217
Status:
COMPLETED
Last Update Posted:
2013-07-24
First Post:
2011-04-14
Brief Title:
A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 800 AM and 1030 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-022062-26 | EUDRACT_NUMBER | Johnson Johnson Pharmaceutical Research Development LLC | None |
| 39393406ALZ1004 | OTHER | None | None |