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Completed

NCT Number: NCT00463372

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizo-Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

George, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-02545920

Drug

Primary outcomes

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

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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Apr 20, 2007
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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