Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00463372
• Date of registration: 18/04/2007
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
• Scientific 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
• Date of first enrolment: October 2006
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00463372
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 1

Countries of recruitment

South Africa

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with DSM-IV diagnosis of schizophrenia or schizo-affective disorder for whom
antipsychotic monotherapy is indicated.

- Subjects must be free from an acute exacerbation of psychosis for at least 3 months
prior to screening.

- Current Clinical Global Impression (CGI) of Severity of Illness score = 3.

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic
disease (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing).

- Evidence or history of a primary DSM-IV axis I diagnosis other than schizophrenia or
schizoaffective disorder.

- Any condition possibly affecting drug absorption (e.g., gastrectomy).



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Schizo-affective Disorder

Intervention(s)

Drug: PF-02545920

Primary Outcome(s)

Pharmacokinetic endpoints: Primary: AUCtau, Tmax and Cmax of PF-02545920 and PF-01001252 on Days 1 and 13.

Safety endpoints: physical and neurological examination, adverse event reports, clinical laboratory tests, vital signs, and 12-lead ECGs throughout the conduct of the study.

Secondary Outcome(s)

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.

Secondary ID(s)

A8241002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors