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A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01829048
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Schizophrenia
Interventions Drug: PF-02545920
Drug: Placebo
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2) PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description Participants received PF-02545920 15 milligram (mg) orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days). Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days). Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days. Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days). Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Period Title: Overall Study
Started 6 8 7 14 2
Completed 6 8 7 12 2
Not Completed 0 0 0 2 0
Reason Not Completed
Withdrawal by Subject             0             0             0             2             0
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2) PF-02545920 (Cohort 3) Placebo (Cohort 3) Total
Hide Arm/Group Description Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days). Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days). Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days. Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days). Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days. Total of all reporting groups
Overall Number of Baseline Participants 6 8 7 14 2 37
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 7 participants 14 participants 2 participants 37 participants
less than (<) 18 years 0 0 0 0 0 0
18-44 years 1 7 1 5 2 16
45-64 5 1 6 9 0 21
Greater or equal to (>=) 65 0 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 7 participants 14 participants 2 participants 37 participants
Female
2
  33.3%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
3
   8.1%
Male
4
  66.7%
8
 100.0%
6
  85.7%
14
 100.0%
2
 100.0%
34
  91.9%
1.Primary Outcome
Title Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
Hide Description ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extrapyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item was scored on a 6-point scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Additionally, 4 Clinical Global Impression of Severity (CGI-S) items were assessed on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill): CGI-S parkinsonism; CGI-S dystonia; CGI-S dyskinesia; CGI-S akathisia.
Time Frame Day 0 (Baseline) up to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
ESRS-A Parkinsonism -0.2  (1.60) -0.3  (0.46) 0.1  (1.21)
ESRS-A Dystonia 0.0  (0.00) 0.0  (0.00) -0.1  (0.38)
ESRS-A Dyskinesia 0.0  (0.00) 0.0  (0.00) -0.1  (0.38)
ESRS-A Akathisia 0.0  (0.00) 0.5  (0.93) 0.0  (0.00)
CGI-S Parkinsonism 0.0  (0.63) 0.0  (0.00) 0.0  (0.58)
CGI-S Dystonia 0.0  (0.00) 0.0  (0.00) -0.1  (0.38)
CGI-S Dyskinesia 0.0  (0.00) 0.0  (0.00) -0.1  (0.38)
CGI-S Akathisia 0.0  (0.00) 0.1  (0.35) 0.0  (0.00)
2.Primary Outcome
Title Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
Hide Description ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extrapyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Additionally, 4 CGI-S items were assessed on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill): CGI-S parkinsonism; CGI-S dystonia; CGI-S dyskinesia; CGI-S akathisia.
Time Frame Day 0 (Baseline) up to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 12 2
Mean (Standard Deviation)
Unit of Measure: Units on a scale
ESRS-A Parkinsonism 0.3  (1.50) 0.0  (0.00)
ESRS-A Dystonia 0.0  (0.00) 0.0  (0.00)
ESRS-A Dyskinesia 0.0  (0.00) 0.0  (0.00)
ESRS-A Akathisia 0.6  (1.38) 0.0  (0.00)
CGI-S Parkinsonism 0.2  (0.58) 0.0  (0.00)
CGI-S Dystonia 0.0  (0.00) 0.0  (0.00)
CGI-S Dyskinesia 0.0  (0.00) 0.0  (0.00)
CGI-S Akathisia 0.3  (0.78) 0.0  (0.00)
3.Primary Outcome
Title Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
Hide Description Data relevant to the assessment of suicidality was mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories were assessed.
Time Frame Day 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
C-CASA Event Code 1 0 0 0
C-CASA Event Code 2 0 0 0
C-CASA Event Code 3 0 0 0
C-CASA Event Code 4 0 0 0
C-CASA Event Code 7 0 0 0
4.Primary Outcome
Title Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
Hide Description Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories were assessed.
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 5 8 6
Measure Type: Number
Unit of Measure: Participants
C-CASA Event Code 1 0 0 0
C-CASA Event Code 2 0 0 0
C-CASA Event Code 3 0 0 0
C-CASA Event Code 4 0 0 0
C-CASA Event Code 7 0 0 0
5.Primary Outcome
Title Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
Hide Description Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories were assessed.
Time Frame Follow-up (any day between Day 17 and 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
C-CASA Event Code 1 0 0 0
C-CASA Event Code 2 0 0 0
C-CASA Event Code 3 0 0 0
C-CASA Event Code 4 0 0 0
C-CASA Event Code 7 0 0 0
6.Primary Outcome
Title Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
Hide Description Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories were assessed.
Time Frame Day 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Unit of Measure: Participants
C-CASA Event Code 1 0 0
C-CASA Event Code 2 0 0
C-CASA Event Code 3 0 0
C-CASA Event Code 4 0 0
C-CASA Event Code 7 0 0
7.Primary Outcome
Title Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
Hide Description Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories were assessed.
Time Frame Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 12 2
Measure Type: Number
Unit of Measure: Participants
C-CASA Event Code 1 0 0
C-CASA Event Code 2 0 0
C-CASA Event Code 3 0 0
C-CASA Event Code 4 0 0
C-CASA Event Code 7 0 0
8.Primary Outcome
Title Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
Hide Description Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories were assessed.
Time Frame Follow-up (any day between Day 26 and 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 12 2
Measure Type: Number
Unit of Measure: Participants
C-CASA Event Code 1 0 0
C-CASA Event Code 2 0 0
C-CASA Event Code 3 0 0
C-CASA Event Code 4 0 0
C-CASA Event Code 7 0 0
9.Primary Outcome
Title Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)
Hide Description A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems was performed at Screening. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards assessment of subject reported symptoms and performed at other time points than Screening.
Time Frame Screening up to Follow-up (any day between Day 17 and 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
0 0 0
10.Primary Outcome
Title Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)
Hide Description A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems was performed at Screening. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards assessment of subject reported symptoms and performed at other time points than Screening.
Time Frame Screening up to Follow-up (any day between Day 26 and 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Unit of Measure: Participants
1 0
11.Primary Outcome
Title Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)
Hide Description The neurological examination included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger-nose, heel-shin, Romberg, tandem walking, positional and gaze-evoked nystagmus.
Time Frame Day 0 up to Follow-up (any day between Day 17 and 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
2 0 1
12.Primary Outcome
Title Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)
Hide Description The neurological examination included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger-nose, heel-shin, Romberg, tandem walking, positional and gaze-evoked nystagmus.
Time Frame Day 0 up to Follow-up (any day between Day 26 and 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Unit of Measure: Participants
0 0
13.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)
Hide Description An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to last subject visit that were absent before treatment or that worsened relative to pretreatment state.
Time Frame The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
5 5 3
14.Primary Outcome
Title Number of Participants With TEAEs (Cohort 3)
Hide Description An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to last subject visit that were absent before treatment or that worsened relative to pretreatment state.
Time Frame The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Unit of Measure: Participants
9 1
15.Primary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)
Hide Description The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Time Frame Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
4 4 5
16.Primary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)
Hide Description The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Time Frame Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 12 2
Measure Type: Number
Unit of Measure: Participants
11 0
17.Primary Outcome
Title Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Hide Description Vital signs included blood pressure (BP; supine and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic >=30 millimeters of mercury (mm Hg) change from baseline in same posture, systolic <90 mm Hg; diastolic >=20 mm Hg change from baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine/sitting): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.
Time Frame Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
Supine systolic BP < 90 mm Hg 1 1 0
Standing systolic BP < 90 mm Hg 0 1 0
Increase in supine systolic BP >= 30 mm Hg 1 1 1
Increase in standing systolic BP >= 30 mm Hg 1 0 0
Increase in supine diastolic BP >= 20 mm Hg 2 0 1
Increase in standing diastolic BP >= 20 mm Hg 1 0 1
Decrease in supine systolic BP >= 30 mm Hg 0 1 1
Decrease in standing systolic BP >= 30 mm Hg 0 1 2
Decrease in supine diastolic BP >= 20 mm Hg 0 3 1
Decrease in standing diastolic BP >= 20 mm Hg 1 2 1
18.Primary Outcome
Title Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Hide Description Vital signs included BP (supine and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic >=30 mm Hg change from baseline in same posture, systolic <90 mm Hg; diastolic >=20 mm Hg change from baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine/sitting): <40 or >120 bpm; Standing: <40 or >140 bpm.
Time Frame Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Unit of Measure: Participants
Increase in supine systolic BP >= 30 mm Hg 2 0
Increase in standing systolic BP >= 30 mm Hg 1 1
Increase in supine diastolic BP >= 20 mm Hg 1 0
Decrease in supine systolic BP >= 30 mm Hg 2 0
Decrease in standing systolic BP >= 30 mm Hg 6 1
Decrease in supine diastolic BP >= 20 mm Hg 3 0
Decrease in standing diastolic BP >= 20 mm Hg 7 1
19.Primary Outcome
Title Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Hide Description 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other time points as specified in timeframe. ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline was greater than (>) 200 msec; or increase >=50% when baseline was less than or equal to (<=) 200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), corrected QT interval (QTc interval): >=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged); absolute change 30 - <60 (borderline), >=60 msec (prolonged).
Time Frame Day 0 (Baseline) up to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
Overall Number of Participants Analyzed 6 8 7
Measure Type: Number
Unit of Measure: Participants
0 0 0
20.Primary Outcome
Title Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Hide Description 12-lead ECG (triplicate)was performed on Day 0 and 12-lead ECG (singlet) was performed at other time points as specified in timeframe. ECG criteria of potential clinical concern were 1), PR interval: >=300 msec; >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval: >=500 msec, QTcF interval: absolute value >=450 - <480 msec (borderline), >=480 msec (prolonged); absolute change 30 - <60 (borderline), >=60 msec (prolonged).
Time Frame Screening up to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Unit of Measure: participants
0 0
21.Primary Outcome
Title Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)
Hide Description [Not Specified]
Time Frame 0 hour (predose) on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
45.07  (27.560) 40.25  (31.465)
22.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
Hide Description [Not Specified]
Time Frame 25 minutes (post dose) on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
116.8  (72.996) 138.3  (106.99)
23.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
Hide Description [Not Specified]
Time Frame 1 hour 30 minutes (post dose) on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
154.0  (48.248) 151.1  (64.913)
24.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
Hide Description [Not Specified]
Time Frame 5 hours (post dose) on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
62.38  (31.441) 59.15  (33.294)
25.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
Hide Description [Not Specified]
Time Frame 24 hours (post dose) on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days).
Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days).
Overall Number of Participants Analyzed 5 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
24.16  (21.032) 21.11  (21.859)
26.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)
Hide Description [Not Specified]
Time Frame 0 hour (predose) on Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
42.71  (24.256)
27.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)
Hide Description [Not Specified]
Time Frame 25 minutes (post dose) Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
156.1  (92.032)
28.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)
Hide Description [Not Specified]
Time Frame 1 hour 30 minutes (post dose) on Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
156.4  (53.842)
29.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)
Hide Description [Not Specified]
Time Frame 5 hours (post dose) on Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
61.30  (23.764)
30.Primary Outcome
Title Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)
Hide Description [Not Specified]
Time Frame 24 hours (post dose) on Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Arm/Group Title PF-02545920 (Cohort 3)
Hide Arm/Group Description:
Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days).
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
20.85  (13.798)
Time Frame From the time the subject had taken at least 1 dose of study treatment through last subject visit. For serious AEs (SAEs), the time began from the subject provided informed consent through 28 calendar days post last administration of study drug.
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2) PF-02545920 (Cohort 3) Placebo (Cohort 3)
Hide Arm/Group Description Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days). Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days). Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days. Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days). Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
All-Cause Mortality
PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2) PF-02545920 (Cohort 3) Placebo (Cohort 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2) PF-02545920 (Cohort 3) Placebo (Cohort 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%)   0/7 (0.00%)   0/14 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-02545920 (Cohort 1) PF-02545920 (Cohort 2) Placebo (Cohorts 1 and 2) PF-02545920 (Cohort 3) Placebo (Cohort 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   5/8 (62.50%)   3/7 (42.86%)   9/14 (64.29%)   1/2 (50.00%) 
Eye disorders           
Blepharospasm * 1  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/2 (0.00%) 
Eye irritation * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Gastrointestinal disorders           
Constipation * 1  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/14 (7.14%)  0/2 (0.00%) 
Dry mouth * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Haemorrhoids * 1  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/14 (0.00%)  0/2 (0.00%) 
Toothache * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
General disorders           
Gait disturbance * 1  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/14 (0.00%)  0/2 (0.00%) 
Infections and infestations           
Otitis externa * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Investigations           
Orthostatic heart rate response increased * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Muscle twitching * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Myalgia * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Nervous system disorders           
Akathisia * 1  1/6 (16.67%)  3/8 (37.50%)  0/7 (0.00%)  3/14 (21.43%)  0/2 (0.00%) 
Cognitive disorder * 1  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/2 (0.00%) 
Disturbance in attention * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Dystonia * 1  1/6 (16.67%)  2/8 (25.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Extrapyramidal disorder * 1  1/6 (16.67%)  0/8 (0.00%)  0/7 (0.00%)  3/14 (21.43%)  0/2 (0.00%) 
Headache * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  4/14 (28.57%)  0/2 (0.00%) 
Oromandibular dystonia * 1  1/6 (16.67%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Paraesthesia * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/2 (50.00%) 
Somnolence * 1  5/6 (83.33%)  3/8 (37.50%)  0/7 (0.00%)  7/14 (50.00%)  1/2 (50.00%) 
Tremor * 1  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/14 (0.00%)  0/2 (0.00%) 
Psychiatric disorders           
Abnormal dreams * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Euphoric mood * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  0/2 (0.00%) 
Insomnia * 1  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/2 (0.00%) 
Psychotic disorder * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/2 (0.00%) 
Vascular disorders           
Orthostatic hypotension * 1  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01829048    
Other Study ID Numbers: A8241018
First Submitted: March 6, 2013
First Posted: April 11, 2013
Results First Submitted: November 20, 2017
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018