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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
39
Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data
Placebo capsules every 12 hours for 10 days
Pfizer Investigational Site
Glendale, California, United States
Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
Time frame: 22 days
Adverse Events
Time frame: 22 Days
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035
Time frame: 12 Days
Positive and Negative Syndrome Scale
Time frame: 16 days
Clinical Global Impression of Severity and Improvement
Time frame: 16 days
Extrapyramidal Symptom Rating Scale - Abbreviated
Time frame: 16 days
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