Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia
Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Apr 2009
Shorter than P25 for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedMarch 19, 2010
October 1, 2009
5 months
April 3, 2009
March 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
22 days
Adverse Events
22 Days
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035
12 Days
Secondary Outcomes (3)
Positive and Negative Syndrome Scale
16 days
Clinical Global Impression of Severity and Improvement
16 days
Extrapyramidal Symptom Rating Scale - Abbreviated
16 days
Study Arms (2)
PF-04802540
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Glendale, California, 91206, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 6, 2009
Study Start
April 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
March 19, 2010
Record last verified: 2009-10