SchizophreniaPhase 1NCT00892320
A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers
A Phase 1 study testing ER OROS paliperidone 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 effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety and tolerability. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ER OROS paliperidone
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to May 2004
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Japanese volunteers must have been born in Japan of Japanese parents and not lived outside of Japan for more than 5 years
- Female volunteers must be 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) before entry and throughout the study, have a negative serum beta-HCG pregnancy test at screening and a negative urine pregnancy test on Day -1
- Volunteers must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Volunteers must sign informed consent document for pharmacogenomic testing
- However, participation in the genetic testing component is not mandatory for participation in the remainder of the study
- Volunteers must have a weight as defined by Body Mass Index or Quetelet Index (weight [kg]/height (m)²) within the range of 18.0 - 25.0, extremes included and must be normotensive with supine (5 min) blood pressure between the range of 100-139 mm Hg systolic and 60-89 mm Hg diastolic
- Volunteers must be healthy on the basis of a pre-study physical examination, medical history, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 3 weeks before the first dose. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only on condition that the investigator judges that the deviations are not clinically significant. For liver function tests (AST, ALT, bilirubin) the values must be within 2 times the upper limit of the normal reference ranges
- Volunteers must smoke less than 10 cigarettes per day and agree not to change smoking habits during the study
Who cannot join
- Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, psychiatric, or immunologic disorders
- History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- Inability to swallow study medication (volunteers may not chew, divide, dissolve, or crush the study medication)
- History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse
- Drug allergy to risperidone, paliperidone or any of its excipients
- Use of concomitant medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) and hormonal contraceptives. All other medication must have been stopped at least 14 days before the first dose in the study
Show all 9Show fewer
- At screening, 2 and 3 minutes after standing, experience a decrease of greater than or equal to 20 mmHg systolic blood pressure, a decrease of greater than or equal to 10 mmHg diastolic blood pressure, or an increase of greater than or equal to 20 beats per minute in heart rate or with symptoms of lightheadedness, dizziness, or fainting upon standing from the supine position
- Positive serology tests for hepatitis B, C or HIV
- Female volunteers that are pregnant, nursing, or planning to become pregnant
About this study
Official title: A Randomized, Open-label, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Subjects
The purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety and tolerability.
Read the detailed description
This study was designed as a randomized, open-label, single-center, crossover study to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults. Of the 20 Japanese volunteers who are to be enrolled, at least 6 are to be men and 6 are to be women. All volunteers will receive single doses of 3 mg ER OROS paliperidone with and without a standard Japanese breakfast. There will be a 1-week washout between treatments, for a total treatment duration of approximately 2 weeks. Volunteers are to be randomly assigned to 1 of 2 treatment sequence groups (fed and fasted; fasted and fed). The pharmacokinetics of paliperidone will be assessed for 96 hours after each dosing. Safety and tolerability will be monitored throughout the study. Prior to initiating clinical trials in Japan, a food effect study is required to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in Japanese adults.
3 mg tablets, single oral dose, once under fasting and once under fed conditions
- Conditions
- Schizophrenia
- Being tested
- ER OROS paliperidone
- Keywords
- Schizophrenia, mood stabilizers, antipsychotics, ER OROS paliperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER OROS paliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults
Secondary outcomes (1)
to evaluate the safety and tolerability of ER OROS paliperidone in healthy Japanese adults
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startMar 2004
- Study completionMay 2004
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
- 20 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
- NCT00892320
- Sponsor's protocol ID
- CR004936
- Status last verified
- Apr 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 Randomized, Open-label, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT00892320
- Acronym / sponsor ID
- CR004936
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, mood stabilizers, antipsychotics, ER OROS paliperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- May 2004 (actual)
- First posted
- 4 May 2009 (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 effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety and tolerability.
Detailed description
This study was designed as a randomized, open-label, single-center, crossover study to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults. Of the 20 Japanese volunteers who are to be enrolled, at least 6 are to be men and 6 are to be women. All volunteers will receive single doses of 3 mg ER OROS paliperidone with and without a standard Japanese breakfast. There will be a 1-week washout between treatments, for a total treatment duration of approximately 2 weeks. Volunteers are to be randomly assigned to 1 of 2 treatment sequence groups (fed and fasted; fasted and fed). The pharmacokinetics of paliperidone will be assessed for 96 hours after each dosing. Safety and tolerability will be monitored throughout the study. Prior to initiating clinical trials in Japan, a food effect study is required to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in Japanese adults.
3 mg tablets, single oral dose, once under fasting and once under fed conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Japanese volunteers must have been born in Japan of Japanese parents and not lived outside of Japan for more than 5 years
- Female volunteers must be 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) before entry and throughout the study, have a negative serum beta-HCG pregnancy test at screening and a negative urine pregnancy test on Day -1
- Volunteers must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Volunteers must sign informed consent document for pharmacogenomic testing
- However, participation in the genetic testing component is not mandatory for participation in the remainder of the study
Key exclusion criteria (9 listed)
- Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, psychiatric, or immunologic disorders
- History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- Inability to swallow study medication (volunteers may not chew, divide, dissolve, or crush the study medication)
- History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse
- Drug allergy to risperidone, paliperidone or any of its excipients
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 |
|---|---|---|
| ER OROS paliperidone | Drug | – |
Primary outcome
to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults
1 secondary outcome
to evaluate the safety and tolerability of ER OROS paliperidone in healthy Japanese adults
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 study of the effect of food on the pharmacokinetics of ER OROS paliperidone in healthy Japanese volunteersLink 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 ER OROS paliperidone 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 8 inclusion and 9 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 effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults. 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.