- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00791713
A Study of the Effects of Paroxetine on the Pharmacokinetics of Paliperidone ER
A Randomized, Open-label, Single-center, Crossover Study of the Potential Effects of Paroxetine on the Pharmacokinetics of a Single Dose of Paliperidone Extended-release in Healthy Men
Study Overview
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 patients will receive 2 single doses of 3 mg paliperidone ER; and end of study evaluations upon completion of all the study procedures in Period 2 or at early withdrawal. All volunteers will receive each of the following 2 treatments in random order: Treatment A: 1 tablet of 3 mg paliperidone ER in the fasted state; Treatment B: one 20 mg paroxetine tablet once a day from Day 1 to Day 13 and 1 tablet of 3 mg paliperidone ER on Day 10 in the fasted state. Successive paliperidone ER administrations will be separated by a washout period of at least 14 days and no more than 28 days. Paroxetine is a potent and selective CYP2D6 inhibitor. Inhibitors of CYP2D6 such as paroxetine have been reported to increase the plasma concentrations of antipsychotics such as perphenazine, clozapine, and risperidone. Because paliperidone ER and paroxetine could potentially be used in combination in schizophrenic patients, the potential for a drug-drug interaction between paroxetine and paliperidone ER needs to be explored.The safety and tolerability of the 3 mg tablet of paliperidone ER administered with and without paroxetine to healthy men will be monitored.
Two single oral doses of paliperidone ER 3-mg; 20-mg paroxetine orally once a day for 13 days
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
- Extensive metabolizer of CYP2D6. Volunteers whose CYP2D6 genotype is unknown should have been phenotyped before the start of the study using dextromethorphan as a probe (i.e., have a dextromethorphan metabolic ratio <0.02, as determined according to the standard procedures of the study center)
- Have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
- Smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes per day and has been following this pattern for at least 3 months before screening
- 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
Exclusion Criteria:
- Poor or intermediate metabolizers of CYP2D6, as determined by genotyping or phenotyping using dextromethorphan
- Known drug allergy to risperidone, paliperidone, paroxetine, or any of their 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To evaluate the effects of a CYP2D6 inhibitor, paroxetine, on the pharmacokinetics of a single dose of orally administered paliperidone ER
|
Secondary Outcome Measures
Outcome Measure |
---|
To evaluate the safety and tolerability of the 3 mg tablet of paliperidone ER administered with and without paroxetine to healthy men
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR007561
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Rakitzi, StavroulaActive, not recruiting
-
Peking UniversityNot yet recruitingTreatment-resistant Schizophrenia
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
Clinical Trials on Paliperidone ER
-
Watson PharmaceuticalsCompletedAnemia, Iron-Deficiency | Hemodialysis | Kidney Failure, ChronicUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedPsychotic Disorders | Schizophrenia | Bipolar DisorderUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Janssen Research & Development, LLCCompletedPsychotic Disorders | Schizophrenia | Schizophrenic Disorders | Dementia PraecoxUnited States, Belgium, Poland, Bulgaria, India, Romania, Russian Federation, Ukraine, Korea, Republic of, Estonia, Finland
-
Janssen PharmaceuticaCompleted
-
Janssen-Cilag B.V.Completed
-
Xian-Janssen Pharmaceutical Ltd.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed