Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073320
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2003-11-19
Brief Title:
Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Pharmacokinetics Tolerability and Safety of Paliperidone After Repeated Intramuscular Injection of Paliperidone Palmitate in the Arm or the Buttock of Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the pharmacokinetic parameters blood concentrations of im paliperidone palmitate after administration in 2 different injection sites deltoid or gluteal
Detailed Description:
An im paliperidone palmitate long-acting formulation is under development with the aim to provide a sustained and stable level of paliperidone during each treatment cycle The goal of this study is to determine the similarity in pharmacokinetic blood levels and safety profile after 2 intramuscular injections of paliperidone palmitate in the arm deltoid muscle and the buttock gluteal muscle in the dose range that will be covered in later Phase 3 trials 25 - 150 mg eq This is a repeated-dose open-label parallel group study in patients with schizophrenia The study consists of an up to 5-day screening period an up to 3-day tolerability period a 14-day washout period and a 64-day treatment period As paliperidone is the active metabolite of risperidone all patients will be exposed to oral risperidone during the screening period to confirm that they do not develop allergic reactions to risperidone and to help the investigator to assign patients to 1 of the 2 treatment doses There will be a washout of at least 2 weeks after the last oral risperidone intake before patients receive the first injection of paliperidone palmitate Each treatment group arm or buttock injection will receive 2 consecutive im injections of the long-acting formulation of paliperidone palmitate with a one-week interval Whole blood samples will be collected for the determination of paliperidone palmitate and paliperidone concentrations in plasma Whole blood samples will be obtained by venipuncture needle stick immediately before pre-dose and at 4 8 12 24 48 72 and 96 hours after the 1st and 2nd injections of paliperidone palmitate Following the collection of the 96-hour blood sample after the 2nd injection additional samples will be collected every 3 to 7 days through the end of the 64-day treatment period Safety will assessed throughout the study by monitoring adverse events changes in clinical laboratory results tardive dyskinesia will be rated using the Abnormal Involuntary Movement Scale AIMS akathisia will be rated according to the Barnes Akathisia Rating Scale BARS extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating Scale SAS physical examinations electrocardiograms ECGs and patient evaluation of the injection site Paliperidone palmitate 25 or 150 mg eq 2 im doses administered at a 1-week interval Depending on the randomized treatment group each patient will receive 3 doses of oral risperidone either 1 mg once daily for 3 days or 2 mg once on the 1st day 4 mg once on the 2nd day and 6 mg once on the 3rd day
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