SchizophreniaPhase 1NCT00892541
A Study of the Potential Effects of Trimethoprim on the Pharmacokinetics of ER OROS Paliperidone
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 purpose of this study is to evaluate the effects of an organic cation transporter inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone and to assess the safety and tolerability of the treatments in healthy male volunteers. 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?
- ER OROS paliperidone
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Nov 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 18 to 55 years, inclusive
- Volunteers must have signed 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
- Body Mass Index (BMI, weight [kg]/height [m²]) range of 18 to 28 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, 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 subject can be included only if the investigator judges that the deviations are not clinically significant
- Creatinine clearance value greater than or equal to 80 mL/min
- Signed an informed consent for genetic testing, indicating whether the volunteer does or does not wish to participate in the genetic part of the study.
Who cannot join
- Drug allergy to risperidone, paliperidone, trimethoprim, any of its excipients or history of hypersensitivity to heparin, in case a heparin lock will be used
- Past or current history of folic acid deficiency or megaloblastic anemia
- Recent history of alcohol or substance abuse or dependence or a positive test result for the urine drug screen at screening
- Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurological (including seizures, cerebrovascular disorders), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrinal, hematological or immunological disease. History of any cancer, with the exception of basal cell carcinomas
- At screening, has a 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
- Bradycardia (heart rate <45 bpm) as determined by screening ECG
- A positive result for any of the tests for hepatitis B, C, and human immunodeficiency virus (HIV).
About this study
Official title: Investigation of the Potential Effects of Trimethoprim on the Pharmacokinetics of ER OROS Paliperidone in Healthy Male Subjects
The purpose of this study is to evaluate the effects of an organic cation transporter inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone and to assess the safety and tolerability of the treatments in healthy male volunteers.
Read the detailed description
This study was designed as a single center, open-label, randomized, 2 treatment period crossover study in healthy male volunteers. The study consists of a screening period (within 21 days before the first study drug administration) before randomization; an open-label treatment phase consisting of 2 periods during which subjects will receive a single oral dose of ER OROS paliperidone alone (Treatment A) or in combination with 200 mg trimethoprim twice daily (Treatment B); and end-of-study evaluations upon completion of all the study procedures in Period 2 or early withdrawal. The pharmacokinetic blood and urine samples will be collected over a 96 hour period after ER OROS paliperidone administration. Successive ER OROS paliperidone administrations will be separated by at least 14 days. Given that the main elimination route of paliperidone is renal clearance and about half of this is through active secretion in the renal tubule, competition for this route of elimination can occur when other actively secreted drugs are coadministered. Therefore, the possible influence on the renal excretion of paliperidone will be investigated when a competitor for active renal secretion, trimethoprim, is coadministered. Safety and tolerability will be monitored throughout the study. Treatment A: a single oral dose of 6 mg ER OROS paliperidone on Day 1; Treatment B: a 200 mg trimethoprim tablet twice daily from Day 1 to Day 8 and a single oral dose of 6 mg ER OROS paliperidone on Day 5.
- Conditions
- Schizophrenia
- Being tested
- ER OROS paliperidone
- Keywords
- Schizophrenia, Mood disorders, Antipsychotic drugs, Renal secretion, ER OROS paliperidone
- 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.
ER OROS paliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of an organic cation transporter inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone
Secondary outcomes (1)
To evaluate the safety and tolerability of the treatments in healthy male volunteers
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 startOct 2004
- Study completionNov 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
- 30 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
- NCT00892541
- Sponsor's protocol ID
- CR004150
- 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
- Investigation of the Potential Effects of Trimethoprim on the Pharmacokinetics of ER OROS Paliperidone in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00892541
- Acronym / sponsor ID
- CR004150
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mood disorders, Antipsychotic drugs, Renal secretion, ER OROS paliperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Nov 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 purpose of this study is to evaluate the effects of an organic cation transporter inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone and to assess the safety and tolerability of the treatments in healthy male volunteers.
Detailed description
This study was designed as a single center, open-label, randomized, 2 treatment period crossover study in healthy male volunteers. The study consists of a screening period (within 21 days before the first study drug administration) before randomization; an open-label treatment phase consisting of 2 periods during which subjects will receive a single oral dose of ER OROS paliperidone alone (Treatment A) or in combination with 200 mg trimethoprim twice daily (Treatment B); and end-of-study evaluations upon completion of all the study procedures in Period 2 or early withdrawal. The pharmacokinetic blood and urine samples will be collected over a 96 hour period after ER OROS paliperidone administration. Successive ER OROS paliperidone administrations will be separated by at least 14 days. Given that the main elimination route of paliperidone is renal clearance and about half of this is through active secretion in the renal tubule, competition for this route of elimination can occur when other actively secreted drugs are coadministered. Therefore, the possible influence on the renal excretion of paliperidone will be investigated when a competitor for active renal secretion, trimethoprim, is coadministered. Safety and tolerability will be monitored throughout the study. Treatment A: a single oral dose of 6 mg ER OROS paliperidone on Day 1; Treatment B: a 200 mg trimethoprim tablet twice daily from Day 1 to Day 8 and a single oral dose of 6 mg ER OROS paliperidone on Day 5.
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 (7 listed)
- Male, aged 18 to 55 years, inclusive
- Volunteers must have signed 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
- Body Mass Index (BMI, weight [kg]/height [m²]) range of 18 to 28 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, 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 subject can be included only if the investigator judges that the deviations are not clinically significant
Key exclusion criteria (7 listed)
- Drug allergy to risperidone, paliperidone, trimethoprim, any of its excipients or history of hypersensitivity to heparin, in case a heparin lock will be used
- Past or current history of folic acid deficiency or megaloblastic anemia
- Recent history of alcohol or substance abuse or dependence or a positive test result for the urine drug screen at screening
- Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurological (including seizures, cerebrovascular disorders), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrinal, hematological or immunological disease. History of any cancer, with the exception of basal cell carcinomas
- At screening, has a 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
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 effects of an organic cation transporter inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone
1 secondary outcome
To evaluate the safety and tolerability of the treatments in healthy male volunteers
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 potential effects of trimethoprim on the pharmacokinetics of ER OROS 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 & 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 7 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 effects of an organic cation transporter inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone. 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.