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

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.

Key facts

Study ID

NCT01559272

Run by

Janssen Research & Development, LLC

People needed

328

Starts

2008-02-21

Expected to finish

2014-05-24

Last updated by the study team

2017-09-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Cerritos, California, United States
• Study site — Garden Grove, California, United States
• Study site — Glendale, California, United States
• Study site — National City, California, United States
• Study site — Paramount, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — DeSoto, Texas, United States
• Study site — Aalst, Belgium
• Study site — Diest, Belgium
• Study site — Burgas, Bulgaria
• Study site — Zagreb, Croatia
• Study site — Beer Yaakov, Israel
• Study site — Hod HaSharon, Israel
• Study site — Ramat Gan, Israel
• Study site — Johor Bahru, Malaysia
• Study site — Kuala Lumpur, Malaysia
• Study site — Perak, Malaysia
• Study site — Bratislava, Slovakia
• Study site — Michalovce, Slovakia
• Study site — Rimavská Sobota, Slovakia
• Study site — Bloemfontein, South Africa
• Study site — Cape Town, South Africa

Full record on ClinicalTrials.gov

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