Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
|ClinicalTrials.gov Identifier: NCT00463372|
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : September 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizo-Affective Disorder||Drug: PF-02545920||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase I, Investigator And Subject-Blind (Sponsor Unblinded), Placebo-Controlled Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-02545920 After Multiple Oral Dose Administration In Subjects With Stable Schizophrenia|
|Study Start Date :||October 2006|
|Study Completion Date :||May 2007|
- Safety endpoints: physical and neurological examination, adverse event reports, clinical laboratory tests, vital signs, and 12-lead ECGs throughout the conduct of the study.
- Pharmacokinetic endpoints: Primary: AUCtau, Tmax and Cmax of PF-02545920 and PF-01001252 on Days 1 and 13.
- Secondary efficacy endpoints include: PANSS, CGI-S, CGI-I, CDSS, CNSVS VS-M cognitive battery, ESRS-A and SSS change from baseline to day 12.
- Secondary PK endpoints include AUClast, t1/2, Cavg, Cmax/Cmin ratio on Day 13, and urinary excretion parameters (renal clearance and amount excreted over the dosing interval) of PF-02545920 and PF-01001252 as data permit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463372
|Pfizer Investigational Site|
|George, South Africa|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|