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

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

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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