Clinical trial NCT01829048: A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Official title: A Randomized, Double-blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Adjunctive Safety, Tolerability And Pharmacokinetics Of Pf-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: PF-02545920
safety
schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.


Eligibility criteria: Inclusion Criteria:

* Psychiatrically stable subjects with schizophrenia.
* Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
* Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion Criteria:

* History of seizures or of a condition with risk of seizures.
* Subjects who have had electroconvulsive therapy within the 6 months prior to randomization.
* Pregnant or nursing females, and females of child bearing potential.

Primary outcomes:
measure: Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
timeFrame: Day 0 (Baseline) up to Day 10
measure: Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
timeFrame: Day 0 (Baseline) up to Day 18
measure: Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
timeFrame: Day 0 (Baseline)
measure: Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
timeFrame: Day 11
measure: Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
timeFrame: Follow-up (any day between Day 17 and 20)
measure: Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
timeFrame: Day 0 (Baseline)
measure: Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
timeFrame: Day 19
measure: Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
timeFrame: Follow-up (any day between Day 26 and 29)
measure: Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)
timeFrame: Screening up to Follow-up (any day between Day 17 and 20)
measure: Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)
timeFrame: Screening up to Follow-up (any day between Day 26 and 29)
measure: Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)
timeFrame: Day 0 up to Follow-up (any day between Day 17 and 20)
measure: Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)
timeFrame: Day 0 up to Follow-up (any day between Day 26 and 29)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)
timeFrame: The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)
measure: Number of Participants With TEAEs (Cohort 3)
timeFrame: The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)
measure: Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)
timeFrame: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
measure: Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)
timeFrame: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
measure: Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
timeFrame: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
measure: Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
timeFrame: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
timeFrame: Day 0 (Baseline) up to Day 10
measure: Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
timeFrame: Screening up to Day 18
measure: Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)
timeFrame: 0 hour (predose) on Day 10
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
timeFrame: 25 minutes (post dose) on Day 10
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
timeFrame: 1 hour 30 minutes (post dose) on Day 10
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
timeFrame: 5 hours (post dose) on Day 10
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
timeFrame: 24 hours (post dose) on Day 10
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)
timeFrame: 0 hour (predose) on Day 18
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)
timeFrame: 25 minutes (post dose) Day 18
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)
timeFrame: 1 hour 30 minutes (post dose) on Day 18
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)
timeFrame: 5 hours (post dose) on Day 18
measure: Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)
timeFrame: 24 hours (post dose) on Day 18
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: