SchizophreniaPhase 1NCT01559272
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia
A Phase 1 study testing Paliperidone IR (Period 1), Paliperidone palmitate F015 (Panel A: treatment group 1) and Paliperidone palmitate F015 (Panel A: treatment group 2) in people with Schizophrenia, run by Janssen Research & Development, LLC at 36 sites in 11 countries.
Trial summary
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone IR (Period 1), Paliperidone palmitate F015 (Panel A: treatment group 1) and Paliperidone palmitate F015 (Panel A: treatment group 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 36 sitesin 11 countries
- Study dates
- 21 Feb 2008to 24 May 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
36 sites in 11 countries.
36 sites in 11 countries
United States10 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Cerritos, California
Study site
DeSoto, Texas
Study site
Garden Grove, California
Study site
Glendale, California
Study site
Little Rock, Arkansas
Study site
National City, California
Study site
Paramount, California
Study site
Philadelphia, Pennsylvania
Spain5 sites
Study site
Badajoz
Study site
Badalona
Study site
Barcelona
Study site
Seville
Study site
Zamora
Israel3 sites
Study site
Beer Yaakov
Study site
Hod HaSharon
Study site
Ramat Gan
Malaysia3 sites
Study site
Johor Bahru
Study site
Kuala Lumpur
Study site
Perak
Slovakia3 sites
Study site
Bratislava
Study site
Michalovce
Study site
Rimavská Sobota
About this study
Official 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
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.
Read the detailed description
This is a multicenter, randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be initiated simultaneously) study in 4 panels (A, B, C and D). Each panel will comprise 2 single-dose treatment periods. In Period 1, all patients from the 4 panels will receive an intramuscular (i.m.) injection with 1 mg paliperidone as an immediate release (IR) solution to assess tolerability and allergic or hypersensitivity reactions potentially related to paliperidone, and to establish the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of paliperidone palmitate versus paliperidone IR. Patients in Panels A and C will receive an i.m. injection with 1 mg paliperidone IR solution in the gluteal muscle, and patients in Panel B and D will receive an i.m. injection with 1 mg paliperidone IR solution in the deltoid or gluteal muscle. Patients who tolerate this injection and have completed all assessments on Day 5 of Period 1 will be enrolled in Period 2. In Period 2, patients will receive a single dose of 3-month paliperidone palmitate i.m. injection at the dosages defined for each panel. The study drug injection will be followed by a 96-hour observation period in Period 1, and a 364-day or 544-day observation period in Period 2. Successive study drug administrations will be separated by a washout period (period when receiving no treatment) of at least 7 and no more than 21 days. The total study length for all patients is from 53 weeks to a maximum of 58 weeks. Patients in Panel B, if consented, and Panel D will participate in the extension period of approximately 26 weeks in order to obtain additional assessments to be able to characterize the pharmacokinetics (PK) profile. Pharmacokinetics explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. Therefore, for those who participate in the extension period, the total study duration will be approximately 84 weeks.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone IR (Period 1), Paliperidone palmitate F015 (Panel A: treatment group 1), Paliperidone palmitate F015 (Panel A: treatment group 2), Paliperidone palmitate F015 (Panel B: treatment group 1), Paliperidone palmitate F015 (Panel B: treatment group 2)
- Keywords
- Schizophrenia, Paliperidone palmitate, R092670, Paliperidone, 3-month formulation, Pharmacokinetics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone IR (Period 1)Drug
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)Drug
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)Drug
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)Drug
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)Drug
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)Drug
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)Drug
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)Drug
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 F016Drug
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)Drug
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)Drug
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)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Panel A | Experimental | Panel A consists of 2 treatment groups Receives: Drug: Paliperidone IR (Period 1); Drug: Paliperidone palmitate F015 (Panel A: treatment group 1); Drug: Paliperidone palmitate F015 (Panel A: treatment group 2) |
| Panel B | Experimental | Panel B consists of 5 treatment groups Receives: Drug: Paliperidone IR (Period 1); Drug: Paliperidone palmitate F015 (Panel B: treatment group 1); Drug: Paliperidone palmitate F015 (Panel B: treatment group 2); Drug: Paliperidone palmitate F015 (Panel B: treatment group 3); Drug: Paliperidone palmitate F015 (Panel B: treatment group 4); Drug: Paliperidone palmitate F015 (Panel B: treatment group 5) |
| Panel C | Experimental | Panel C consists of 1 treatment group Receives: Drug: Paliperidone IR (Period 1); Drug: Paliperidone palmitate F016 |
| Panel D | Experimental | Panel D consists of 4 treatment groups Receives: Drug: Paliperidone IR (Period 1); Drug: Paliperidone palmitate F015 (Panel D: treatment group 1); Drug: Paliperidone palmitate F015 (Panel D: treatment group 2); Drug: Paliperidone palmitate F015 (Panel D: treatment group 3); Drug: Paliperidone palmitate F015 (Panel D: treatment group 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Paliperidone (Period 1)
Measured: 14 time points over 96 hours
Plasma concentration of Paliperidone (Period 2)
Measured: 29 time points over 544 days
Secondary outcomes (17)
The change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) (Period 1)
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Measured: 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)
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Measured: Baseline and 544 days
The change from baseline in Clinical Global Impression (CGI-S) (Period 1)
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 subject. 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 subjects". Higher scores indicate worsening.
Measured: Baseline and 96 hours
Changes in Clinical Global Impression (CGI-S) observed across multiple time points between baseline and 544 days (Period 2)
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 subject. 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 subjects". Higher scores indicate worsening.
Measured: Baseline and 544 days
Changes from Baseline in Abnormal Involuntary Movement Scale (AIMS) for the ratings of dyskinesia (Period 1)
The AIMS consists of 12 items to measure involuntary movements known as dyskinesia, with scores ranging from 0 (none) to 4 (severe).
Measured: Baseline and 96 hours
Changes in Abnormal Involuntary Movement Scale (AIMS) for the ratings of dyskinesia observed across multiple time points between baseline and 544 days (Period 2)
The AIMS consists of 12 items to measure involuntary movements known as dyskinesia, with scores ranging from 0 (none) to 4 (severe).
Measured: Baseline and 544 days
Changes from Baseline in Barnes Akathisia Rating Scale (BARS) for the ratings of akathisia (Period 1)
The BARS is a scale to assess the presence and severity of drug-induced akathisia (inner restlessness). It is scored as follows: Objective Akathisia, Subjective Awareness of Restlessness and Subjective Distress Related to Restlessness are rated on a 4-point scale from 0 (normal or absence of restlessness) to 3 (intense restlessness). The Global Clinical Assessment of Akathisia uses a 6-point scale ranging from 0 (absent) to 5 (severe akathisia).
Measured: Baseline and 96 hours
Changes in Barnes Akathisia Rating Scale (BARS) for the ratings of akathisia observed across multiple time points between baseline and 544 days (Period 2)
The BARS is a scale to assess the presence and severity of drug-induced akathisia (inner restlessness). It is scored as follows: Objective Akathisia, Subjective Awareness of Restlessness and Subjective Distress Related to Restlessness are rated on a 4-point scale from 0 (normal or absence of restlessness) to 3 (intense restlessness). The Global Clinical Assessment of Akathisia uses a 6-point scale ranging from 0 (absent) to 5 (severe akathisia).
Measured: Baseline and 544 days
Changes from Baseline in Simpson and Angus Rating Scale (SAS) for the ratings of general extrapyramidal symptoms (EPS) (Period 1)
The SAS is a 10-item instrument used to evaluate the presence and severity of extrapyramidal symptoms (EPS), such as akinesia (inability to initiate movement) and akathisia. Items are rated for severity on a 0 (normal) to 4 (severe symptoms) scale.
Measured: Baseline and 96 hours
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)
The SAS is a 10-item instrument used to evaluate the presence and severity of extrapyramidal symptoms (EPS), such as akinesia (inability to initiate movement) and akathisia. Items are rated for severity on a 0 (normal) to 4 (severe symptoms) scale.
Measured: Baseline and 544 days
Changes from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) (Period 1)
The Columbia-Suicide Severity Rating Scale (C-SSRS) rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
Measured: 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)
The Columbia-Suicide Severity Rating Scale (C-SSRS) rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
Measured: Baseline and 544 days
Evaluation of the Injection Site (Period 1)
The investigator will evaluate the site of injection for redness, swelling, and induration. The evaluation will be assessed as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Measured: 96 hours
Evaluation of the Injection Site (Period 2)
The investigator will evaluate the site of injection for redness, swelling, and induration. The evaluation will be assessed as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Measured: Baseline through day 112
Incidence of Adverse Events as a Measure of Safety and Tolerability
Measured: Approximately 84 weeks
Number of patients with abnormal clinical laboratory tests
Measured: Approximately 84 weeks
Number of patients with abnormal findings in electrocardiogram, vital signs and physical examination
Measured: Approximately 84 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study start21 Feb 2008
- Primary completion9 Apr 2014
- Study completion24 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559272
- Sponsor's protocol ID
- CR012652
- Other IDs
- R092670PSY1005, 2007-003581-17
- Status last verified
- Sep 2017
- First submitted
- 13 Mar 2012
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27743205Samtani 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.
PubMed 27333588Gopal 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.
PubMed 26306819
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01559272
- Acronym / sponsor ID
- CR012652
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone palmitate, R092670, Paliperidone, 3-month formulation, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2008 (actual)
- Primary completion
- 9 Apr 2014 (actual)
- Study completion
- 24 May 2014 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.
Detailed description
This is a multicenter, randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be initiated simultaneously) study in 4 panels (A, B, C and D). Each panel will comprise 2 single-dose treatment periods. In Period 1, all patients from the 4 panels will receive an intramuscular (i.m.) injection with 1 mg paliperidone as an immediate release (IR) solution to assess tolerability and allergic or hypersensitivity reactions potentially related to paliperidone, and to establish the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of paliperidone palmitate versus paliperidone IR. Patients in Panels A and C will receive an i.m. injection with 1 mg paliperidone IR solution in the gluteal muscle, and patients in Panel B and D will receive an i.m. injection with 1 mg paliperidone IR solution in the deltoid or gluteal muscle. Patients who tolerate this injection and have completed all assessments on Day 5 of Period 1 will be enrolled in Period 2. In Period 2, patients will receive a single dose of 3-month paliperidone palmitate i.m. injection at the dosages defined for each panel. The study drug injection will be followed by a 96-hour observation period in Period 1, and a 364-day or 544-day observation period in Period 2. Successive study drug administrations will be separated by a washout period (period when receiving no treatment) of at least 7 and no more than 21 days. The total study length for all patients is from 53 weeks to a maximum of 58 weeks. Patients in Panel B, if consented, and Panel D will participate in the extension period of approximately 26 weeks in order to obtain additional assessments to be able to characterize the pharmacokinetics (PK) profile. Pharmacokinetics explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. Therefore, for those who participate in the extension period, the total study duration will be approximately 84 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel A | Experimental | Drug: Paliperidone IR (Period 1), Drug: Paliperidone palmitate F015 (Panel A: treatment group 1), Drug: Paliperidone palmitate F015 (Panel A: treatment group 2)Panel A consists of 2 treatment groups |
| Panel B | Experimental | Drug: Paliperidone IR (Period 1), Drug: Paliperidone palmitate F015 (Panel B: treatment group 1), Drug: Paliperidone palmitate F015 (Panel B: treatment group 2), Drug: Paliperidone palmitate F015 (Panel B: treatment group 3), Drug: Paliperidone palmitate F015 (Panel B: treatment group 4), Drug: Paliperidone palmitate F015 (Panel B: treatment group 5)Panel B consists of 5 treatment groups |
| Panel C | Experimental | Drug: Paliperidone IR (Period 1), Drug: Paliperidone palmitate F016Panel C consists of 1 treatment group |
| Panel D | Experimental | Drug: Paliperidone IR (Period 1), Drug: Paliperidone palmitate F015 (Panel D: treatment group 1), Drug: Paliperidone palmitate F015 (Panel D: treatment group 2), Drug: Paliperidone palmitate F015 (Panel D: treatment group 3), Drug: Paliperidone palmitate F015 (Panel D: treatment group 4)Panel D consists of 4 treatment groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Panel A, Panel B, Panel C, Panel D |
| 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. | Drug | Panel A |
| 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. | Drug | Panel A |
| 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. | Drug | Panel B |
| 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. | Drug | Panel B |
| 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. | Drug | Panel B |
| 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. | Drug | Panel B |
| 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. | Drug | Panel B |
| Paliperidone palmitate F016Type= 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. | Drug | Panel C |
| 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. | Drug | Panel D |
| 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. | Drug | Panel D |
| 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. | Drug | Panel D |
| 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. | Drug | Panel D |
Primary outcome
Plasma concentration of Paliperidone (Period 1)
Time frame: 14 time points over 96 hours
Plasma concentration of Paliperidone (Period 2)
Time frame: 29 time points over 544 days
17 secondary outcomes
The change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) (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
The change from baseline in Clinical Global Impression (CGI-S) (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
Changes from Baseline in Abnormal Involuntary Movement Scale (AIMS) for the ratings of dyskinesia (Period 1)
Time frame: Baseline and 96 hours
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
Changes from Baseline in Barnes Akathisia Rating Scale (BARS) for the ratings of akathisia (Period 1)
Time frame: Baseline and 96 hours
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 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 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 from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) (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
Evaluation of the Injection Site (Period 1)
Time frame: 96 hours
Evaluation of the Injection Site (Period 2)
Time frame: Baseline through day 112
Incidence of Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 84 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 27743205Magnusson 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.
- Derived from this study: PubMed 27333588Samtani 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.
- Derived from this study: PubMed 26306819Gopal 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.
- 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 SchizophreniaLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
36 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paliperidone IR (Period 1), Paliperidone palmitate F015 (Panel A: treatment group 1) and Paliperidone palmitate F015 (Panel A: treatment group 2) in people with Schizophrenia, run by Janssen Research & Development, LLC at 36 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Spain, Israel, Malaysia, Slovakia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Paliperidone (Period 1) (time frame: 14 time points over 96 hours). The study lists 2 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 NCT01559272, which also lists 3 linked publications.
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 18 Sep 2017.