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Immediate release Paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: Jun 8, 2011

Immediate release Paliperidone target and mechanism

ModalitySmall molecule

Also known as Immediate release (IR) Paliperidone

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

Immediate release Paliperidone clinical trials

Immediate release Paliperidone · 1 trial · 2 indications

Phase 1 1
NCT00791349A Study of QT and QTc Intervals in Patients Administered Immediate Release PaliperidoneSchizophrenia
COMPLETED141 Analytics
PHASE1COMPLETED
A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the cardiovascular safety of paliperidone in schizophrenic or schizoaffective patients, with particular attention to the length of the QT/QTc interval. Other ECG parameters, such as QRS and PR intervals, will also be carefully measured

Secondary Endpoints

To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Immediate release (IR) PaliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must have a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV criteria, with no exacerbation of psychosis for at least 3 months prior to screening * Patients must have a normal 12-lead ECG at screening and on Day -1, including: Normal sinus r...

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Frequently asked questions about Immediate release Paliperidone

What is immediate release paliperidone?

Immediate release paliperidone is a small molecule formulation of paliperidone developed by Johnson & Johnson (ticker: JNJ). It is being studied in schizophrenia, a psychiatric condition. The immediate release version is distinct from longer acting formulations because the drug is released promptly after administration rather than being gradually released over time.

What is immediate release paliperidone used for in schizophrenia?

Immediate release paliperidone is being studied for the treatment of schizophrenia. Johnson & Johnson (ticker: JNJ) is the developer of this formulation. The clinical program has focused on patients with schizophrenia, and one completed Phase 1 trial also enrolled patients with schizoaffective disorder alongside schizophrenia.

Who makes immediate release paliperidone?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of immediate release paliperidone. The company has sponsored the clinical research for this formulation, including a completed Phase 1 study evaluating cardiac QT and QTc intervals in patients with schizophrenia and schizoaffective disorder.

What phase is immediate release paliperidone in?

Immediate release paliperidone is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study, NCT00791349, was a randomized, double blind evaluation of QT and QTc intervals in patients administered immediate release paliperidone.

What clinical trials is immediate release paliperidone in?

Immediate release paliperidone has been evaluated in one completed Phase 1 trial, NCT00791349, titled A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone. The trial enrolled 141 patients with schizophrenia or schizoaffective disorder, was randomized and double blind, and included participants aged 18 years and older.

Is immediate release paliperidone the same as IR paliperidone?

Yes, immediate release paliperidone is also known as immediate release (IR) paliperidone. The abbreviation IR refers to the same formulation, in which the drug is released promptly after administration. Both names refer to the small molecule developed by Johnson & Johnson (ticker: JNJ) for schizophrenia.