Status:
COMPLETED
A Pharmacokinetics Study to Evaluate Safety and Tolerability of JNJ-37822681 in Participants With Stable Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
20-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia (psychiatric diso...
Detailed Description
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multi-center (conducted in more than one center), randomized (treatment group assigned by ...
Eligibility Criteria
Inclusion
- Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- known history of schizophrenia of at least 12 months by the referring psychiatrist
- Positive and Negative Syndrome Scale score at Screening less than 70
- Body Mass Index (BMI) between 18 and 35 kilogram divided by square meter inclusive (BMI =weight per square height)
- Female participants must meet any one of the following: postmenopausal (amenorrhea for at least 12 months and Follicle Stimulating Hormone levels of greater than 40 milli-international unit (MIU ) per milliliter at Screening), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise be incapable of pregnancy)
Exclusion
- Any medical condition that could potentially alter the absorption, metabolism or excretion of the study medication, such as Crohn's (serious inflammation of any part of the gastrointestinal tract) disease, liver disease, or renal disease
- Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine or immunologic diseases
- History of neuroleptic malignant syndrome
- Female participants of childbearing potential
- Significant risk of suicidal or violent behavior
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01812642
Start Date
July 1 2008
End Date
December 1 2008
Last Update
March 18 2014
Active Locations (6)
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1
Antwerp, Belgium
2
Berlin, Germany
3
Neuss, Germany
4
Nizny Novgorod, Russia