Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia
Phase 1
Completed
- Conditions
- Schizophrenia
- Interventions
- Drug: PF-04802540Drug: Placebo
- Registration Number
- NCT00876304
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Males or females of non-childbearing capacity aged 18 to 55 years inclusive
- DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months
- Body mass index in the range of 18 to 40 kg/m2 and body weight>45 kg.
Exclusion Criteria
- Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Any condition possibly affecting drug absorption (eg, gastrectomy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04802540 PF-04802540 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale 22 days Plasma concentrations of PF 04802540 and its metabolite, PF 04831035 12 Days Adverse Events 22 Days
- Secondary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale 16 days Extrapyramidal Symptom Rating Scale - Abbreviated 16 days Clinical Global Impression of Severity and Improvement 16 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Glendale, California, United States