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

Sponsors and Collaborators:	Pfizer Taisho Pharmaceuticals
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00876304

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 I

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
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

Further study details as provided by Pfizer:

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 ]

Estimated Enrollment:	40
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-04802540: Experimental	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: Placebo Comparator	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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Taisho Pharmaceuticals

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0911004
Study First Received:	April 3, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00876304 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PF-04802540 multiple dose safety study

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009