A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia

Pfizer

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: PF-06412562 3mg BID; Other: Placebo; Drug: PF-06412562 9mg BID; Drug: PF-06412562 45mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02418819

B7441007

Details and patient eligibility

About

This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.

Full description

B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of 3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100 psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with schizophrenia are on background treatment with SOC antipsychotics and other psychotropic medications.

All doses will be administered twice daily, with approximately 12 hours between each dose.

Enrollment: 103 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects with schizophrenia both male and female
2. Evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc).
3. Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to Day 1, including concomitant psychotropic medications.

Exclusion criteria

1. History of seizure
2. Pregnant or nursing females
3. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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103 participants in 4 patient groups, including a placebo group

PF-06412562 3mg

Experimental group

Description:

PF-06412562 3mg BID

Treatment:

Drug: PF-06412562 3mg BID

PF-06412562 9mg

Experimental group

Description:

PF-06412562 9mg BID

Treatment:

Drug: PF-06412562 9mg BID

PF-06412562 45mg

Experimental group

Description:

PF-06412562 45mg BID

Treatment:

Drug: PF-06412562 45mg BID

Placebo

Placebo Comparator group

Description:

Placebo BID

Treatment:

Other: Placebo