A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia
NCT ID: NCT01559272
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
328 participants
INTERVENTIONAL
2008-02-21
2014-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Panel A
Panel A consists of 2 treatment groups
Paliperidone IR (Period 1)
Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle.
Paliperidone palmitate F015 (Panel A: treatment group 1)
Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique A, in the gluteal muscle.
Paliperidone palmitate F015 (Panel A: treatment group 2)
Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique B, in the gluteal muscle.
Panel B
Panel B consists of 5 treatment groups
Paliperidone IR (Period 1)
Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle.
Paliperidone palmitate F015 (Panel B: treatment group 1)
Type= exact number, unit= mg, number= 75, form= injection, route= intramuscular use. Single injection with 75 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 2)
Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 3)
Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 4)
Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Paliperidone palmitate F015 (Panel B: treatment group 5)
Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Panel C
Panel C consists of 1 treatment group
Paliperidone IR (Period 1)
Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle.
Paliperidone palmitate F016
Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F016 in the gluteal muscle.
Panel D
Panel D consists of 4 treatment groups
Paliperidone IR (Period 1)
Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle.
Paliperidone palmitate F015 (Panel D: treatment group 1)
Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel D: treatment group 2)
Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Paliperidone palmitate F015 (Panel D: treatment group 3)
Type= exact number, unit= mg, number=350, form= injection, route= intramuscular use. Single injection with 350 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel D: treatment group 4)
Type= exact number, unit= mg, number=175, form= injection, route= intramuscular use. Single injection with 175 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Interventions
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Paliperidone IR (Period 1)
Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle.
Paliperidone palmitate F015 (Panel A: treatment group 1)
Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique A, in the gluteal muscle.
Paliperidone palmitate F015 (Panel A: treatment group 2)
Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique B, in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 1)
Type= exact number, unit= mg, number= 75, form= injection, route= intramuscular use. Single injection with 75 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 2)
Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 3)
Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel B: treatment group 4)
Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Paliperidone palmitate F015 (Panel B: treatment group 5)
Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Paliperidone palmitate F016
Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F016 in the gluteal muscle.
Paliperidone palmitate F015 (Panel D: treatment group 1)
Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel D: treatment group 2)
Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Paliperidone palmitate F015 (Panel D: treatment group 3)
Type= exact number, unit= mg, number=350, form= injection, route= intramuscular use. Single injection with 350 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
Paliperidone palmitate F015 (Panel D: treatment group 4)
Type= exact number, unit= mg, number=175, form= injection, route= intramuscular use. Single injection with 175 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Little Rock, Arkansas, United States
Cerritos, California, United States
Garden Grove, California, United States
Glendale, California, United States
National City, California, United States
Paramount, California, United States
Atlanta, Georgia, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
DeSoto, Texas, United States
Aalst, , Belgium
Diest, , Belgium
Burgas, , Bulgaria
Zagreb, , Croatia
Beer Yaakov, , Israel
Hod HaSharon, , Israel
Ramat Gan, , Israel
Johor Bahru, , Malaysia
Kuala Lumpur, , Malaysia
Perak, , Malaysia
Bratislava, , Slovakia
Michalovce, , Slovakia
Rimavská Sobota, , Slovakia
Bloemfontein, , South Africa
Cape Town, , South Africa
Incheon, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
Badajoz, , Spain
Badalona, , Spain
Barcelona, , Spain
Seville, , Spain
Zamora, , Spain
Hualien City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Countries
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References
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Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.
Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24.
Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2.
Related Links
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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
Other Identifiers
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R092670PSY1005
Identifier Type: OTHER
Identifier Source: secondary_id
2007-003581-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR012652
Identifier Type: -
Identifier Source: org_study_id