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

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Taisho Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: PF-04802540

Study type

Interventional

Funder types

Industry

Identifiers

NCT00876304
B0911004

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

39 participants in 2 patient groups, including a placebo group

PF-04802540
Experimental group
Treatment:
Drug: PF-04802540
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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