Trial record 1 of 1 for:    NCT00876304
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Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00876304
First received: April 3, 2009
Last updated: March 17, 2010
Last verified: October 2009
  Purpose

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 Intervention Phase
Schizophrenia
Drug: PF-04802540
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Taisho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 22 Days ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of PF 04802540 and its metabolite, PF 04831035 [ Time Frame: 12 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity and Improvement [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Extrapyramidal Symptom Rating Scale - Abbreviated [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876304

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00876304     History of Changes
Other Study ID Numbers: B0911004
Study First Received: April 3, 2009
Last Updated: March 17, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014