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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

NCT00570063

Schizophrenia

TERMINATED PHASE2

Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants

NCT01879722

Schizophrenia

COMPLETED PHASE1

In-Patient Study In Schizophrenic Patients

NCT00197093

Schizophrenia

COMPLETED PHASE1

Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients

NCT00781794

Schizophrenia

WITHDRAWN PHASE1

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

NCT04510298

Schizophrenia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-04802540

Group Type EXPERIMENTAL

PF-04802540

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules every 12 hours for 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Placebo capsules every 12 hours for 10 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No