A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01559272
• Date of registration: 13/03/2012
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia
• Scientific title: A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Paliperidone Palmitate 3-Month Formulation in Subjects With Schizophrenia
• Date of first enrolment: February 21, 2008
• Target sample size: 328
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01559272
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, Bulgaria, Croatia, Israel, Korea, Republic of, Malaysia, Slovakia, South Africa, Spain, Taiwan, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients diagnosed with schizophrenia or schizoaffective disorder, for at least 1 year
before screening

- Clinically stable with no hospitalizations for schizophrenia exacerbation or change in
current antipsychotic medications for 3 months prior to screening

- Stabilized on antipsychotic medications other than risperidone, paliperidone,
ziprasidone, clozapine, thioridazine, or any long acting injectable.

- For panel D only, no detectable plasma concentration of risperidone or paliperidone >
0.1ng/mL at screening. A quantifiable and stable level of paliperidone not exceeding
0.25 ng/mL is allowed if such paliperidone value is explained by (documented) use of
paliperidone palmitate (last dose administered > 12 months prior to baseline)

- Has a total PANSS score of 70 or less at both screening and Day-1 (Period 1)

- Woman is postmenopausal, surgically sterile, abstinent or, if sexually active,
practices an effective method of birth control during participation in the study or
for at least 6 months after the last dose of study drug, whichever is longer

- Woman has negative pregnancy test at screening and on Day -1 of Period 1

- Man agrees to use an adequate contraception method as deemed appropriate by the
investigator and agrees to not donate sperm during participation in the study or for
at least 6 months after the last dose of study drug, whichever is longer

- Body Mass Index (BMI) between 17 and 35 kg/m2 (inclusive). Body weight of at least 50
kg for patients enrolled in panel A, B and C. For patients enrolled in panel D only:
body weight of at least 47 kg

Exclusion Criteria:

- Attempted suicide within 12 months before screening or is at imminent risk of suicide
or violent behavior

- Has diagnosis of alcohol or substance dependence, with the exception of nicotine or
caffeine dependence, within 12 months prior to screening, or diagnosis of substance
abuse within 3 months prior to screening

- Has a positive drug screen test for barbiturates, cocaine, amphetamines or opiates, or
has a positive alcohol screen test unless positive toxicology screen is explained by a
prescribed allowed medication

- Is in his/her first episode of psychosis

- Has a history of or has a current clinically significant medical illness that the
investigator considers should exclude the patients or that could interfere with the
interpretation of the study results

- Has clinically significant abnormal values at screening or at baseline for hematology,
clinical chemistry or for urinalysis, as deemed appropriate by the investigator

- Has a clinically relevant abnormality in the physical examination, vital signs or 12
lead electrocardiogram (ECG) at screening or at baseline as deemed appropriate by the
investigator

- Has a history or presence of circumstances that may increase the risk of the
occurrence of torsade de pointes and/or sudden death in association with the use of
drugs that prolong the QTc interval

- Concomitant use of medications that the investigator considers should exclude the
patients or that could interfere with the interpretation of the study results

- Any other condition or circumstance that the investigator considers should exclude the
patients or that could interfere with the interpretation of the study results



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Paliperidone palmitate F015 (Panel A: treatment group 1)

Drug: Paliperidone palmitate F015 (Panel D: treatment group 1)

Drug: Paliperidone palmitate F016

Drug: Paliperidone palmitate F015 (Panel B: treatment group 5)

Drug: Paliperidone palmitate F015 (Panel D: treatment group 2)

Drug: Paliperidone palmitate F015 (Panel D: treatment group 3)

Drug: Paliperidone palmitate F015 (Panel B: treatment group 1)

Drug: Paliperidone palmitate F015 (Panel B: treatment group 2)

Drug: Paliperidone palmitate F015 (Panel A: treatment group 2)

Drug: Paliperidone palmitate F015 (Panel B: treatment group 3)

Drug: Paliperidone palmitate F015 (Panel B: treatment group 4)

Drug: Paliperidone IR (Period 1)

Drug: Paliperidone palmitate F015 (Panel D: treatment group 4)

Primary Outcome(s)

Plasma concentration of Paliperidone (Period 2) [Time Frame: 29 time points over 544 days]

Plasma concentration of Paliperidone (Period 1) [Time Frame: 14 time points over 96 hours]

Secondary Outcome(s)

Changes from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) (Period 1) [Time Frame: Baseline and 96 hours]

The change from baseline in Clinical Global Impression (CGI-S) (Period 1) [Time Frame: Baseline and 96 hours]

The change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) (Period 1) [Time Frame: Baseline and 96 hours]

Changes from Baseline in Abnormal Involuntary Movement Scale (AIMS) for the ratings of dyskinesia (Period 1) [Time Frame: Baseline and 96 hours]

Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) observed across multiple time points between baseline and 544 days (Period 2) [Time Frame: Baseline and 544 days]

Changes in Barnes Akathisia Rating Scale (BARS) for the ratings of akathisia observed across multiple time points between baseline and 544 days (Period 2) [Time Frame: Baseline and 544 days]

Changes in Simpson and Angus Rating Scale (SAS) for the ratings of general extrapyramidal symptoms (EPS) observed across multiple time points between baseline and 544 days (Period 2) [Time Frame: Baseline and 544 days]

Changes in Abnormal Involuntary Movement Scale (AIMS) for the ratings of dyskinesia observed across multiple time points between baseline and 544 days (Period 2) [Time Frame: Baseline and 544 days]

Evaluation of the Injection Site (Period 2) [Time Frame: Baseline through day 112]

Number of patients with abnormal clinical laboratory tests [Time Frame: Approximately 84 weeks]

Number of patients with abnormal findings in electrocardiogram, vital signs and physical examination [Time Frame: Approximately 84 weeks]

Changes from Baseline in Barnes Akathisia Rating Scale (BARS) for the ratings of akathisia (Period 1) [Time Frame: Baseline and 96 hours]

Changes in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) observed across multiple time points between baseline and 544 days (Period 2) [Time Frame: Baseline and 544 days]

Incidence of Adverse Events as a Measure of Safety and Tolerability [Time Frame: Approximately 84 weeks]

Changes from Baseline in Simpson and Angus Rating Scale (SAS) for the ratings of general extrapyramidal symptoms (EPS) (Period 1) [Time Frame: Baseline and 96 hours]

Changes in Clinical Global Impression (CGI-S) observed across multiple time points between baseline and 544 days (Period 2) [Time Frame: Baseline and 544 days]

Evaluation of the Injection Site (Period 1) [Time Frame: 96 hours]

Secondary ID(s)

CR012652

R092670PSY1005

2007-003581-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors