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Intermediate release Paliperidone

Phase 1

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

Intermediate release Paliperidone target and mechanism

ModalitySmall molecule

Also known as Intermediate release (IR) Paliperidone

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Intermediate release Paliperidone clinical trials

Intermediate release Paliperidone · 1 trial · 2 indications

Phase 1 1
NCT00791284A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver FunctionSchizophrenia
COMPLETED20 Analytics
PHASE1COMPLETED
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate the single-dose pharmacokinetics of IR paliperidone after oral administration to patients with moderate hepatic impairment as compared to patients with normal hepatic function

Secondary Endpoints

To document the plasma protein binding and disposition of the enantiomers of paliperidone and to evaluate the tolerability and safety profile of IR paliperidone in both patient populations
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Intermediate release (IR) PaliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Patients with normal hepatic function:Normotensive at screening, with supine (5 minutes) blood pressure between the range of 95 to 160 mmHg systolic, inclusive, and 55 to 95 mmHg diastolic, inclusive, demographically comparable to the hepatic impairment group with respect to a...

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Frequently asked questions about Intermediate release Paliperidone

What is intermediate release paliperidone?

Intermediate release paliperidone is an investigational small molecule formulation of paliperidone developed by Johnson & Johnson for schizophrenia. It is also known as intermediate release (IR) paliperidone. The formulation has been studied in a Phase 1 pharmacokinetics trial, and no Phase 2 or later trials are recorded.

What is intermediate release paliperidone used for?

Intermediate release paliperidone is being studied for schizophrenia. A Phase 1 trial also enrolled volunteers with hepatic impairment to assess how liver function affects the drug. The program remains in early clinical development, and the formulation has not been approved for any indication.

Who makes intermediate release paliperidone?

Intermediate release paliperidone is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. Johnson & Johnson is the sponsor behind the clinical program for this formulation.

What phase is intermediate release paliperidone in?

Intermediate release paliperidone is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this formulation.

What clinical trials is intermediate release paliperidone in?

Intermediate release paliperidone has been evaluated in one completed Phase 1 trial, NCT00791284, titled A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function. That trial enrolled 20 participants, including healthy volunteers, and examined schizophrenia and hepatic impairment. No active trials are listed.

Is intermediate release paliperidone the same as IR paliperidone?

Yes. Intermediate release paliperidone is also known as intermediate release (IR) paliperidone, so the two names refer to the same investigational formulation. Searches using either name point to the same Johnson & Johnson Phase 1 program in schizophrenia.