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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463372
• Other study ID #: A8241002
• Status: Completed
• Phase: Phase 1
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: September 2007
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo-affective Disorder
• Schizophrenia

Intervention

Drug:
• PF-02545920

Locations

Country	Name	City	State
South Africa	Pfizer Investigational Site	George

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoints: physical and neurological examination, adverse event reports, clinical laboratory tests, vital signs, and 12-lead ECGs throughout the conduct of the study.
Primary	Pharmacokinetic endpoints: Primary: AUCtau, Tmax and Cmax of PF-02545920 and PF-01001252 on Days 1 and 13.
Secondary	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	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.

External Links

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