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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876304
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : March 19, 2010
Information provided by:
Taisho Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: PF-04802540 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : April 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: PF-04802540 Drug: PF-04802540
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 Comparator: Placebo Drug: Placebo
Placebo capsules every 12 hours for 10 days

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876304

United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Taisho Pharmaceutical Co., Ltd. Identifier: NCT00876304     History of Changes
Other Study ID Numbers: B0911004
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: October 2009

Keywords provided by Taisho Pharmaceutical Co., Ltd.:
PF-04802540 multiple dose safety study

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders