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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00463372
First received: April 18, 2007
Last updated: September 17, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizo-Affective Disorder
Drug: PF-02545920
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: October 2006
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463372

Locations
South Africa
Pfizer Investigational Site
George, South Africa
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00463372     History of Changes
Other Study ID Numbers: A8241002
Study First Received: April 18, 2007
Last Updated: September 17, 2007
Health Authority: South Africa: Medicines Control Council in South Africa

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 20, 2014