Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite, PF-01001252, after multiple doses of PF-02545920 administered orally.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||October 2006|
|Study Completion Date:||May 2007|