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A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia

10. september 2013 opdateret af: Janssen Pharmaceutical K.K.

Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia

The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multicenter (study conducted at multiple sites), open label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel-group (each group of participants will be treated at the same time) study. Approximately, 60 participants will be enrolled in the study. This study will consist of a screening phase (maximum 14 days), an observation phase (92 days), and a follow-up phase (98 days). Participants will be randomly assigned to treatment group A, B, or C. During the observation phase, participants will receive injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in the deltoid muscle or gluteal muscle as applicable on Days 1, 8, 36, and 64 alternating between sides (left/right). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, injection site reaction, drug-induced extrapyramidal symptoms scale, and visual analog scale which will be evaluated throughout the study. The total study duration for each participant will be approximately 190 days.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Fase 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:- Participants had to have the capability to provide informed consent in writing to participate in the study

  • Participants with a diagnosis of schizophrenia in accordance with the diagnostic criteria for Diagnostic and Statistical Manual of Mental Disorders -IV-TR (DSM-IV-TR)
  • Participants whose psychiatric symptom is considered stable by the investigator/subinvestigator at the time of giving informed consent
  • Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) in the following 9 items at screening: delusion, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility, uncooperativeness, poor impulse control
  • Participants with an experience of taking a risperidone formulation or a paliperidone formulation by 8 days before the initial day (Day 1) of the study treatment

Exclusion Criteria:- DSM-IV-TR diagnosis other than schizophrenia

  • DSM-IV-TR diagnosis of substance-related disorders within 180 days before the date of screening
  • At a risk of suicide or other-injurious behavior as considered by the investigator/subinvestigator , and participants with a history of suicide attempts
  • Concurrent condition of Parkinson's disease (except for drug-induced extrapyramidal syndrome) - Concurrent condition or history of symptomatic cerebrovascular accident

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment A
Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
Medicin: Paliperidone palmitate
Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
Andre navne:
  • JNS010
Eksperimentel: Treatment B
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
Medicin: Paliperidone palmitate
Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
Andre navne:
  • JNS010
Eksperimentel: Treatment C
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.
Medicin: Paliperidone palmitate
Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
Andre navne:
  • JNS010

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma concentration of unchanged drug (Paliperidone palmitate)
Tidsramme: Days 1 to 190
Days 1 to 190
Plasma concentration of active metabolite (paliperidone)
Tidsramme: Days 1 to 190
Days 1 to 190
Plasma concentration of enantiomer of paliperidone palmitate (R078543)
Tidsramme: Days 1 to 190
Days 1 to 190
Plasma concentration of enantiomer paliperidone palmitate (R078544)
Tidsramme: Days 1 to 190
Days 1 to 190
Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate
Tidsramme: Days 1 to 190
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Days 1 to 190
Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate
Tidsramme: Days 1 to 190
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Days 1 to 190
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate
Tidsramme: Days 1 to 190
The Area Under the Curve From Time Zero to End of Dosing Interval (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 to 190
Number of participants with adverse events
Tidsramme: Up to Day 190
Up to Day 190

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Tidsramme: Screening, Baseline (Day 1), Days 8, 36, 64, and 92
The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Screening, Baseline (Day 1), Days 8, 36, 64, and 92
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score
Tidsramme: Screening, Baseline (Day 1), Days 8, 36, 64, and 92
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Screening, Baseline (Day 1), Days 8, 36, 64, and 92

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Pharmaceutical K.K.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. marts 2010

Datoer for studieregistrering

Først indsendt

10. september 2013

Først indsendt, der opfyldte QC-kriterier

10. september 2013

Først opslået (Skøn)

16. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR100413
  • PALM-JPN-3 (Anden identifikator: Janssen Pharmaceutical K.K., Japan)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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