The primary objective of this study is to evaluate the effects of a CYP2D6 inhibitor, paroxetine, on the pharmacokinetics of a single dose of orally administered paliperidone ER. The safety and tolerability of the 3 mg tablet of paliperidone ER…
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Pharmacokinetic blood- and urine investigation, adverse events reporting,
safety laboratory parameters, vital signs, heart rate, ECG and alcohol breath
test.
Secondary outcome
Not Applicable
Background summary
During this study the effects of a CYP2D6 inhibitor, paroxetine, on the
pharmacokinetics of a single dose of orally administered paliperidone ER will
be investigated. Paliperidone ER is developed for the treatment of
Schizofrenia. Paroxetine is available on the market and is given for e.g.
depression.
In psychiatric patients a combination of both drugs as treatment is possible.
For that reason the pharmacokinetic interaction between both drugs is
investigated.
Study objective
The primary objective of this study is to evaluate the effects of a CYP2D6
inhibitor, paroxetine, on the pharmacokinetics of a single dose of orally
administered paliperidone ER.
The safety and tolerability of the 3 mg tablet of paliperidone ER administered
with and without paroxetine in healthy men will also be assessed.
Study design
This is a randomized, open-label, single-center, 2-treatment, 2 way crossover
study in healthy men.
The study will consist of a screening phase (within 21 days before the first
study drug administration). In the open-label treatment phase there will be 2
treatment periods, during which subjects will receive 2 single doses of 3 mg
paliperidone ER (in one period without paroxetine and in the other period
paroxetine will be administered during 13 days (20 mg per day), where on day 10
a single dose of paliperidone ER will be administered).
End-of-study evaluations will be performed upon completion of all the study
procedures in Period 2 or at early withdrawal.
Successive paliperidone ER administrations will be separated by a washout
period of at least 14 days and no more than 28 days.
The maximum study duration for each subject is 64 days, including the screening
phase.
Intervention
All subjects will receive each of the following 2 treatments in the order
specified by random assignment:
Treatment A: One tablet of 3-mg paliperidone ER in fasted state.
Treatment B: One 20-mg paroxetine tablet per day from Day 1 to 13 and a single
tablet of 3-mg paliperidone ER on Day 10 in fasted state.
Study burden and risks
The associated risks to this study are the occurence of possible side effects
during the use of paliperidone ER and/or paroxetine. The burden of the
subjects are the confinement periods in the unit, venaepuncture and the
insertion of the canula.
Nederland
Nederland
Listed location countries
Age
Inclusion criteria
healthy male subjects, aged 18-55 years, inclusive
Extensive metabolizer of CYP2D6. Subjects whose CYP2D6 genotype is unknown should have been phenotyped before the start of the study.
Exclusion criteria
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
Known history of drug-induced dystonia
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | 2006-001329-25-NL |
CCMO | NL11837.072.06 |