SchizophreniaPhase 1NCT00796471
A Pharmacokinetics and Pharmacodynamics Study Under Fasting and Fed Conditions With Paliperidone Extended-release and Immediate-release Formulations
A Phase 1 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of 2 extended-release (ER) formulations of 2 mg-eq paliperidone in comparison to the 2 mg immediate-release (IR) paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone ER
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Aug 2003
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Acceptable weight as defined by body mass index (weight [kg]/height (m)²) range of 18.0 to 28.0 kg/m², inclusive
- Normotensive with supine (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive
- Healthy on the basis of a prestudy physical examination, medical history, electrocardiogram, and the laboratory results of blood biochemistry, hematology and urinalysis performed within 21 days before the first dose. If the results of the biochemistry, hematology or urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only if the investigator judges that the deviations are not clinically significant. For liver function tests (alanine transaminase, aspartate transaminase, and bilirubin), the values must be contained within 2 times the upper limits of the normal laboratory reference ranges and for renal function tests, the values must be within the normal laboratory reference ranges
- Women must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization and at the discretion of the investigator, total abstinence) before entry and throughout the study, as well as have a negative serum pregnancy test at screening. To ensure continued eligibility, women must have a negative urine test before each dose of study drug (Day -1 for each period).
Who cannot join
- Known allergy or history of significant hypersensitivity to heparin
- Recent history of alcohol or substance abuse. Test positive for the urine drug screen at screening or the urine drug screen or alcohol breath test at Day -1 for Period 1
- Relevant history of any cardiovascular, respiratory neuropsychiatric, renal, hepatic, gastrointestinal (including surgeries, and malabsorption problems), endocrine, or immunologic diseases
- A decrease of greater than or equal to 20 mmHg systolic blood pressure 3 minutes after standing, or with symptoms of lightheadedness, dizziness or fainting upon standing at screening
- Positive result for any of the serology tests (hepatitis B, C and HIV)
- History of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. (Volunteers must agree to refrain from use throughout the study.)
- Drug allergy to risperidone, paliperidone, or any of its excipients
About this study
Official title: A Comparative Evaluation of the Pharmacokinetics and Pharmacodynamics Under Fasting and Fed Conditions of 2 Paliperidone Extended-release Formulations With Paliperidone Oral Solution in Healthy Adults
The purpose of this study is to evaluate the pharmacokinetics of 2 extended-release (ER) formulations of 2 mg-eq paliperidone in comparison to the 2 mg immediate-release (IR) paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations. Additional objectives are to compare the pharmacodynamic effects (postural changes in blood pressure and heart rate), safety, and tolerability are to be evaluated in addition to exploring the relationship between CYP2D6 and CYP3A4/5genotype and paliperidone exposure.
Read the detailed description
This study is designed as a single-center, open-label, randomized, 5 treatment-period, crossover study in healthy adults. The study consists of a screening phase and a treatment phase during which each volunteer will receive 5 treatments of study drug in a random order and separated by a washout period of at least 7 to 14 days. Treatments consist of a single oral dose of: A) paliperidone ER pellet formulation, (2 mg-eq) as 1 capsule of 2.5 mg, fasted; B) the same formulation as A but with food; C) paliperidone-coated ER OROS formulation (2 mg eq) as 2 tablets of 2 mg, fasted; D) the same formulation as C but with food; E) IR paliperidone oral solution, 2 mg (2 mL) of a 1 mg/mL solution, fasted. Alternative paliperidone ER formulations are being developed with the aim to increase the bioavailability without compromising the favorable effect on the orthostatic hypotension as seen with ER OROS paliperidone. Therefore, in this study, the pharmacokinetic and pharmacodynamic properties, as well as the effect of food, of 2 alternative paliperidone ER formulations using different mechanisms to achieve extended release of the drug will be investigated: a multiparticulate ER capsule formulation, containing coated pellets comprised of 3 coating layers, with both immediate and extended drug-release properties (pellet formulation; drug ratio extended- versus immediate-release layer: 9:1), and an OROS trilayer longitudinally compressed tablet formulation (Push-Pull delivery system) (overcoated-OROS formulation). Safety and tolerability will be monitored throughout the study. Single doses of paliperidone ER pellet formulation, (2 mg-eq) as 1 capsule of 2.5 mg, fasted; paliperidone ER pellet formulation, (2 mg-eq) as 1 capsule of 2.5 mg with food (high-fat breakfast); paliperidone-coated OROS ER formulation (2 mg-eq) as 2 tablets of 2 mg, fasted; paliperidone-coated OROS ER formulation (2 mg-eq) as 2 tablets of 2 mg with food (high-fat breakfast); IR paliperidone oral solution, 2 mg (2 mL) of a 1 mg/mL solution, fasted.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Mood Disorders, Antipsychotic drugs, Paliperidone ER
- Medical subject headings
- Schizophrenia, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics of 2 ER formulations of 2 mg-eq paliperidone in comparison with 2 mg IR paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations
Secondary outcomes (1)
To compare the pharmacodynamic effects (postural changes in blood pressure and heart rate) of all treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startJun 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796471
- Sponsor's protocol ID
- CR004282
- Status last verified
- Mar 2010
- First submitted
- 20 Nov 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Pharmacokinetics and Pharmacodynamics Under Fasting and Fed Conditions of 2 Paliperidone Extended-release Formulations With Paliperidone Oral Solution in Healthy Adults
- ClinicalTrials.gov ID
- NCT00796471
- Acronym / sponsor ID
- CR004282
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mood Disorders, Antipsychotic drugs, Paliperidone ER
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Aug 2003 (actual)
- First posted
- 24 Nov 2008 (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 evaluate the pharmacokinetics of 2 extended-release (ER) formulations of 2 mg-eq paliperidone in comparison to the 2 mg immediate-release (IR) paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations. Additional objectives are to compare the pharmacodynamic effects (postural changes in blood pressure and heart rate), safety, and tolerability are to be evaluated in addition to exploring the relationship between CYP2D6 and CYP3A4/5genotype and paliperidone exposure.
Detailed description
This study is designed as a single-center, open-label, randomized, 5 treatment-period, crossover study in healthy adults. The study consists of a screening phase and a treatment phase during which each volunteer will receive 5 treatments of study drug in a random order and separated by a washout period of at least 7 to 14 days. Treatments consist of a single oral dose of: A) paliperidone ER pellet formulation, (2 mg-eq) as 1 capsule of 2.5 mg, fasted; B) the same formulation as A but with food; C) paliperidone-coated ER OROS formulation (2 mg eq) as 2 tablets of 2 mg, fasted; D) the same formulation as C but with food; E) IR paliperidone oral solution, 2 mg (2 mL) of a 1 mg/mL solution, fasted. Alternative paliperidone ER formulations are being developed with the aim to increase the bioavailability without compromising the favorable effect on the orthostatic hypotension as seen with ER OROS paliperidone. Therefore, in this study, the pharmacokinetic and pharmacodynamic properties, as well as the effect of food, of 2 alternative paliperidone ER formulations using different mechanisms to achieve extended release of the drug will be investigated: a multiparticulate ER capsule formulation, containing coated pellets comprised of 3 coating layers, with both immediate and extended drug-release properties (pellet formulation; drug ratio extended- versus immediate-release layer: 9:1), and an OROS trilayer longitudinally compressed tablet formulation (Push-Pull delivery system) (overcoated-OROS formulation). Safety and tolerability will be monitored throughout the study. Single doses of paliperidone ER pellet formulation, (2 mg-eq) as 1 capsule of 2.5 mg, fasted; paliperidone ER pellet formulation, (2 mg-eq) as 1 capsule of 2.5 mg with food (high-fat breakfast); paliperidone-coated OROS ER formulation (2 mg-eq) as 2 tablets of 2 mg, fasted; paliperidone-coated OROS ER formulation (2 mg-eq) as 2 tablets of 2 mg with food (high-fat breakfast); IR paliperidone oral solution, 2 mg (2 mL) of a 1 mg/mL solution, fasted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Acceptable weight as defined by body mass index (weight [kg]/height (m)²) range of 18.0 to 28.0 kg/m², inclusive
- Normotensive with supine (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive
- Healthy on the basis of a prestudy physical examination, medical history, electrocardiogram, and the laboratory results of blood biochemistry, hematology and urinalysis performed within 21 days before the first dose. If the results of the biochemistry, hematology or urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only if the investigator judges that the deviations are not clinically significant. For liver function tests (alanine transaminase, aspartate transaminase, and bilirubin), the values must be contained within 2 times the upper limits of the normal laboratory reference ranges and for renal function tests, the values must be within the normal laboratory reference ranges
- Women must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization and at the discretion of the investigator, total abstinence) before entry and throughout the study, as well as have a negative serum pregnancy test at screening. To ensure continued eligibility, women must have a negative urine test before each dose of study drug (Day -1 for each period).
Key exclusion criteria (7 listed)
- Known allergy or history of significant hypersensitivity to heparin
- Recent history of alcohol or substance abuse. Test positive for the urine drug screen at screening or the urine drug screen or alcohol breath test at Day -1 for Period 1
- Relevant history of any cardiovascular, respiratory neuropsychiatric, renal, hepatic, gastrointestinal (including surgeries, and malabsorption problems), endocrine, or immunologic diseases
- A decrease of greater than or equal to 20 mmHg systolic blood pressure 3 minutes after standing, or with symptoms of lightheadedness, dizziness or fainting upon standing at screening
- Positive result for any of the serology tests (hepatitis B, C and HIV)
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 ER | Drug | – |
Primary outcome
To evaluate the pharmacokinetics of 2 ER formulations of 2 mg-eq paliperidone in comparison with 2 mg IR paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations
1 secondary outcome
To compare the pharmacodynamic effects (postural changes in blood pressure and heart rate) of all treatments
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 8 Jun 2011.
- A pharmacokinetics and pharmacodynamics study under fasting and fed conditions with paliperidone extended-release and immediate-release formulationsLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 inclusion and 7 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 8 Jun 2011. 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?
To evaluate the pharmacokinetics of 2 ER formulations of 2 mg-eq paliperidone in comparison with 2 mg IR paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2011.