A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia

NCT01606254 | Completed Phase 2 Results

• 2 other identifiers: CR013612PALM-JPN-2
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Palmitate; JNS010

Outcome Measures

Primary Outcomes (17)

• Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8

  The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).

  Day 8

• Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36

  The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.

  Day 36

• Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64

  The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.

  Day 64

• Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92

  The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.

  Day 92

• Maximum Observed Plasma Concentration (Cmax) of Paliperidone

  The Cmax is defined as maximum observed analyte concentration.

  Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal

• Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

  The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.

  Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal

• Plasma Paliperidone Concentration at Steady State (Css av)

  The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).

  Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal

• Paliperidone Plasma Decay Half-Life (t1/2)

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 8

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 22

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 50

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 78

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 92

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 120

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 162

• Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218

  The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).

  Day 218

Secondary Outcomes (2)

• Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline, Day 8, 22, 50, 78 and 92

• Number of Participants With Clinical Global Impression Severity (CGI-S) Score

  Baseline, Day 8, 22, 50, 78 and 92

Study Arms (4)

Paliperidone palmitate 50 mg

EXPERIMENTAL

Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64.

Drug: Paliperidone palmitate

Paliperidone palmitate 100 mg

EXPERIMENTAL

Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64.

Drug: Paliperidone palmitate

Paliperidone palmitate 150 mg

EXPERIMENTAL

Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64.

Drug: Paliperidone palmitate

Paliperidone palmitate 150/ 50 mg

EXPERIMENTAL

Paliperidone palmitate 150 mg intramuscular injection on Day 1 and paliperidone palmitate 50 mg intramuscular injection on Days 8, 36 and 64.

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate DRUG

Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64.

Also known as: JNS010

Paliperidone palmitate 100 mg; Paliperidone palmitate 150 mg; Paliperidone palmitate 150/ 50 mg; Paliperidone palmitate 50 mg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
• Participants may be inpatients or outpatients
• Participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent
• Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) at screening

You may not qualify if:

• Participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
• Participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence)
• Participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)
• Participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder)
• Participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Ichikawa, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Medical Director
• Organization: Janssen Pharm KK Japan

81-3-4411

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 25, 2012
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 5, 2013
• Results First Posted: April 18, 2013

Record last verified: 2013-05

Locations

JP (1)