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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876304

Enrollment

Registered

2009-04-06

Start date

2009-04-30

Completion date

2009-09-30

Last updated

2010-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

PF-04802540 multiple dose safety study

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.

Interventions

DRUGPF-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

DRUGPlacebo

Placebo capsules every 12 hours for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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).

Design outcomes

Primary

Measure	Time frame
Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale	22 days
Adverse Events	22 Days
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035	12 Days

Secondary

Measure	Time frame
Positive and Negative Syndrome Scale	16 days
Clinical Global Impression of Severity and Improvement	16 days
Extrapyramidal Symptom Rating Scale - Abbreviated	16 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026