SchizophreniaPhase 1NCT00791167
A Study of the Dose Proportionality of Extended Release Paliperidone
A Phase 1 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone ER
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Aug 2006
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ( weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
- Have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
- Healthy on the basis of a prestudy physical examination, medical history, 12-lead ECG, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. If the results of the serum chemistry, 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 renal function tests, the values must be within the normal laboratory reference ranges
Who cannot join
- Known drug allergy to risperidone, paliperidone, or any of its excipients
- Known history of drug-induced dystonia
- Recent history of alcohol or substance abuse
- Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
- History of any cancer, with the exception of basal cell carcinoma
- At screening, has signs of autonomic dysfunction as indicated by a sustained decrease of > 20 mmHg in systolic blood pressure or a decrease of >10 mmHg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
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- Bradycardia (heart rate <50 bpm) as determined by screening 12-lead ECG
- A positive test result (or history of) for any of the serology tests (hepatitis B and C, and human immunodeficiency virus) at screening
- 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
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of study drug. Exception for acetaminophen (paracetamol) or ibuprofen, which is allowed up to 3 days before first dose of study drug
About this study
Official title: Evaluation of the Dose Proportionality of Two Dose Strengths (1.5 and 3 mg) of Extended-release Paliperidone After a Single Administration to Healthy Men
The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.
Read the detailed description
This is a randomized, open label, single center, single dose, 2 treatment, 2 way crossover study. It consists of 3 phases: A screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2) during which volunteers will receive a single oral 1.5 or 3 mg dose of study drug; and end of study evaluations upon completion of all the study procedures in Period 2. All volunteers will receive each of the following 2 treatments in random order: Treatment A: One tablet of 1.5 mg paliperidone ER to-be-marketed formulation in the fasted state; Treatment B: One tablet of 3 mg paliperidone ER Phase 3 formulation in the fasted state. Successive study drug administrations will be separated by a washout period of at least 9 days and no more than 21 days. A 1.5-mg dose of paliperidone ER was selected to be studied as the availability of a 1.5-mg tablet would make dose-adjustments across the existing range of doses of paliperidone ER easier in patients with reduced renal function or tolerability issues. Safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men will be monitored throughout the study.
A single oral doses of 1.5 mg and 3 mg paliperidone ER
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Mood Disorders, Antipsychotic drugs, Schizophrenia, 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 dose-proportionality of 1.5 and 3-mg tablets of paliperidone ER
Secondary outcomes (1)
To document the pharmacokinetics of a 1.5-mg dose of paliperidone ER in healthy men and to assess the safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJun 2006
- Study completionAug 2006
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
- 58 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 and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791167
- Sponsor's protocol ID
- CR011437
- Status last verified
- Feb 2009
- First submitted
- 13 Nov 2008
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dose Proportionality of Two Dose Strengths (1.5 and 3 mg) of Extended-release Paliperidone After a Single Administration to Healthy Men
- ClinicalTrials.gov ID
- NCT00791167
- Acronym / sponsor ID
- CR011437
- Conditions
- Schizophrenia
- Keywords
- Mood Disorders, Antipsychotic drugs, Schizophrenia, Paliperidone ER
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 14 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 purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.
Detailed description
This is a randomized, open label, single center, single dose, 2 treatment, 2 way crossover study. It consists of 3 phases: A screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2) during which volunteers will receive a single oral 1.5 or 3 mg dose of study drug; and end of study evaluations upon completion of all the study procedures in Period 2. All volunteers will receive each of the following 2 treatments in random order: Treatment A: One tablet of 1.5 mg paliperidone ER to-be-marketed formulation in the fasted state; Treatment B: One tablet of 3 mg paliperidone ER Phase 3 formulation in the fasted state. Successive study drug administrations will be separated by a washout period of at least 9 days and no more than 21 days. A 1.5-mg dose of paliperidone ER was selected to be studied as the availability of a 1.5-mg tablet would make dose-adjustments across the existing range of doses of paliperidone ER easier in patients with reduced renal function or tolerability issues. Safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men will be monitored throughout the study.
A single oral doses of 1.5 mg and 3 mg paliperidone ER
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index ( weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
- Have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
- Healthy on the basis of a prestudy physical examination, medical history, 12-lead ECG, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. If the results of the serum chemistry, 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 renal function tests, the values must be within the normal laboratory reference ranges
Key exclusion criteria (10 listed)
- Known drug allergy to risperidone, paliperidone, or any of its excipients
- Known history of drug-induced dystonia
- Recent history of alcohol or substance abuse
- Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
- History of any cancer, with the exception of basal cell carcinoma
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 dose-proportionality of 1.5 and 3-mg tablets of paliperidone ER
1 secondary outcome
To document the pharmacokinetics of a 1.5-mg dose of paliperidone ER in healthy men and to assess the safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men
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 May 2011.
- A study of the dose proportionality of extended release paliperidoneLink 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 and 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 3 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 May 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 dose-proportionality of 1.5 and 3-mg tablets of paliperidone ER. 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 18 May 2011.