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SchizophreniaPhase 1NCT01942382

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

A Phase 1 study testing Paliperidone palmitate in people with Schizophrenia, run by Janssen Pharmaceutical K.K..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Paliperidone palmitate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
No sites listed yet
Study dates
Apr 2009to Mar 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Schizophrenia
Being tested
Paliperidone palmitate
Keywords
Schizophrenia, JNS010, Paliperidone Palmitate, Clinical Pharmacology
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paliperidone palmitateDrug

    Also called JNS010

    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.

Study groups in NCT01942382
Study groupRoleWhat they receive
Treatment AExperimentalParticipants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
Receives: Drug: Paliperidone palmitate
Treatment BExperimentalParticipants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
Receives: Drug: Paliperidone palmitate
Treatment CExperimentalParticipants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.
Receives: Drug: Paliperidone palmitate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentration of unchanged drug (Paliperidone palmitate)

    Measured: Days 1 to 190

  2. Plasma concentration of active metabolite (paliperidone)

    Measured: Days 1 to 190

  3. Plasma concentration of enantiomer of paliperidone palmitate (R078543)

    Measured: Days 1 to 190

  4. Plasma concentration of enantiomer paliperidone palmitate (R078544)

    Measured: Days 1 to 190

  5. Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate

    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

    Measured: Days 1 to 190

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate

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

    Measured: Days 1 to 190

  7. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate

    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.

    Measured: Days 1 to 190

  8. Number of participants with adverse events

    Measured: Up to Day 190

Secondary outcomes (2)

  1. Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

    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.

    Measured: Screening, Baseline (Day 1), Days 8, 36, 64, and 92

  2. Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score

    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.

    Measured: Screening, Baseline (Day 1), Days 8, 36, 64, and 92

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2013 (estimated)
  2. Study startApr 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01942382
Sponsor's protocol ID
CR100413
Other IDs
PALM-JPN-3
Status last verified
Sep 2013
First submitted
10 Sep 2013
Last updated
16 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paliperidone palmitate in people with Schizophrenia, run by Janssen Pharmaceutical K.K..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentration of unchanged drug (Paliperidone palmitate) (time frame: Days 1 to 190). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.

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