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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04802540
Placebo
Sponsored by
Taisho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring PF-04802540 multiple dose safety study

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04802540

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
Adverse Events
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035

Secondary Outcome Measures

Positive and Negative Syndrome Scale
Clinical Global Impression of Severity and Improvement
Extrapyramidal Symptom Rating Scale - Abbreviated

Full Information

First Posted
April 3, 2009
Last Updated
March 17, 2010
Sponsor
Taisho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00876304
Brief Title
Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
PF-04802540 multiple dose safety study

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04802540
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04802540
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules every 12 hours for 10 days
Primary Outcome Measure Information:
Title
Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
Time Frame
22 days
Title
Adverse Events
Time Frame
22 Days
Title
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035
Time Frame
12 Days
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale
Time Frame
16 days
Title
Clinical Global Impression of Severity and Improvement
Time Frame
16 days
Title
Extrapyramidal Symptom Rating Scale - Abbreviated
Time Frame
16 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0911004&StudyName=Multiple%20Dose%20Safety%20Study%20of%20PF-04802540%20in%20Subjects%20With%20Schizophrenia
Description
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Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia

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