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Completed

NCT Number: NCT00876304

Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders 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

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females of non-childbearing capacity aged 18 to 55 years inclusive
  • DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months
  • Body mass index in the range of 18 to 40 kg/m2 and body weight>45 kg.

Exclusion criteria

  • Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption (eg, gastrectomy).

Treatment and study plan

PF-04802540

Drug

Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data

Placebo

Drug

Placebo capsules every 12 hours for 10 days

Primary outcomes

  1. Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale

    Time frame: 22 days

  2. Adverse Events

    Time frame: 22 Days

  3. Plasma concentrations of PF 04802540 and its metabolite, PF 04831035

    Time frame: 12 Days

Secondary outcomes

  1. Positive and Negative Syndrome Scale

    Time frame: 16 days

  2. Clinical Global Impression of Severity and Improvement

    Time frame: 16 days

  3. Extrapyramidal Symptom Rating Scale - Abbreviated

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 6, 2009
Registry last updated
Mar 19, 2010

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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