Trial Outcomes & Findings for A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia (NCT NCT01829048)
NCT ID: NCT01829048
Last Updated: 2018-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Day 0 (Baseline) up to Day 10
Results posted on
2018-08-20
Participant Flow
Participant milestones
| Measure |
PF-02545920 (Cohort 1)
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
PF-02545920 (Cohort 3)
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).
|
Placebo (Cohort 3)
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
7
|
14
|
2
|
|
Overall Study
COMPLETED
|
6
|
8
|
7
|
12
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
PF-02545920 (Cohort 1)
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
PF-02545920 (Cohort 3)
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).
|
Placebo (Cohort 3)
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Baseline characteristics by cohort
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
PF-02545920 (Cohort 3)
n=14 Participants
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).
|
Placebo (Cohort 3)
n=2 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
less than (<) 18 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
|
Age, Customized
18-44 years
|
1 participants
n=93 Participants
|
7 participants
n=4 Participants
|
1 participants
n=27 Participants
|
5 participants
n=483 Participants
|
2 participants
n=36 Participants
|
16 participants
n=10 Participants
|
|
Age, Customized
45-64
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
9 participants
n=483 Participants
|
0 participants
n=36 Participants
|
21 participants
n=10 Participants
|
|
Age, Customized
Greater or equal to (>=) 65
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
34 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Day 10Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
ESRS-A Parkinsonism
|
-0.2 Units on a scale
Standard Deviation 1.60
|
-0.3 Units on a scale
Standard Deviation 0.46
|
0.1 Units on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
ESRS-A Dystonia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
-0.1 Units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
ESRS-A Dyskinesia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
-0.1 Units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
ESRS-A Akathisia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.5 Units on a scale
Standard Deviation 0.93
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
CGI-S Parkinsonism
|
0.0 Units on a scale
Standard Deviation 0.63
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
CGI-S Dystonia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
-0.1 Units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
CGI-S Dyskinesia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
-0.1 Units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
CGI-S Akathisia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.1 Units on a scale
Standard Deviation 0.35
|
0.0 Units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Day 18Population: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
ESRS-A Parkinsonism
|
0.3 Units on a scale
Standard Deviation 1.50
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
ESRS-A Dystonia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
ESRS-A Dyskinesia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
ESRS-A Akathisia
|
0.6 Units on a scale
Standard Deviation 1.38
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
CGI-S Parkinsonism
|
0.2 Units on a scale
Standard Deviation 0.58
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
CGI-S Dystonia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
CGI-S Dyskinesia
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
CGI-S Akathisia
|
0.3 Units on a scale
Standard Deviation 0.78
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
PRIMARY outcome
Timeframe: Day 0 (Baseline)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
C-CASA Event Code 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
C-CASA Event Code 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
C-CASA Event Code 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
C-CASA Event Code 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
C-CASA Event Code 7
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 11Population: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=5 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=6 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
C-CASA Event Code 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
C-CASA Event Code 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
C-CASA Event Code 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
C-CASA Event Code 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
C-CASA Event Code 7
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Follow-up (any day between Day 17 and 20)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
C-CASA Event Code 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
C-CASA Event Code 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
C-CASA Event Code 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
C-CASA Event Code 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
C-CASA Event Code 7
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Baseline)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=14 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
C-CASA Event Code 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
C-CASA Event Code 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
C-CASA Event Code 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
C-CASA Event Code 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
C-CASA Event Code 7
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 19Population: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
C-CASA Event Code 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
C-CASA Event Code 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
C-CASA Event Code 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
C-CASA Event Code 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
C-CASA Event Code 7
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Follow-up (any day between Day 26 and 29)Population: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
C-CASA Event Code 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
C-CASA Event Code 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
C-CASA Event Code 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
C-CASA Event Code 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
C-CASA Event Code 7
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Screening up to Follow-up (any day between Day 17 and 20)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening up to Follow-up (any day between Day 26 and 29)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=14 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 up to Follow-up (any day between Day 17 and 20)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Follow-up (any day between Day 26 and 29)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=14 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)
|
5 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=14 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With TEAEs (Cohort 3)
|
9 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)
|
4 Participants
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)Population: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)
|
11 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Supine systolic BP < 90 mm Hg
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Standing systolic BP < 90 mm Hg
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Increase in supine systolic BP >= 30 mm Hg
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Increase in standing systolic BP >= 30 mm Hg
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Increase in supine diastolic BP >= 20 mm Hg
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Increase in standing diastolic BP >= 20 mm Hg
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Decrease in supine systolic BP >= 30 mm Hg
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Decrease in standing systolic BP >= 30 mm Hg
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Decrease in supine diastolic BP >= 20 mm Hg
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Decrease in standing diastolic BP >= 20 mm Hg
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=14 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Decrease in standing systolic BP >= 30 mm Hg
|
6 Participants
|
1 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Increase in supine systolic BP >= 30 mm Hg
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Increase in standing systolic BP >= 30 mm Hg
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Increase in supine diastolic BP >= 20 mm Hg
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Decrease in supine systolic BP >= 30 mm Hg
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Decrease in supine diastolic BP >= 20 mm Hg
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Decrease in standing diastolic BP >= 20 mm Hg
|
7 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (Baseline) up to Day 10Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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).
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
n=7 Participants
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening up to Day 18Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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).
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=14 Participants
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).
|
PF-02545920 (Cohort 2)
n=2 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: 0 hour (predose) on Day 10Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)
|
45.07 nanogram/milliliter (ng/mL)
Standard Deviation 27.560
|
40.25 nanogram/milliliter (ng/mL)
Standard Deviation 31.465
|
—
|
PRIMARY outcome
Timeframe: 25 minutes (post dose) on Day 10Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
|
116.8 ng/mL
Standard Deviation 72.996
|
138.3 ng/mL
Standard Deviation 106.99
|
—
|
PRIMARY outcome
Timeframe: 1 hour 30 minutes (post dose) on Day 10Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
|
154.0 ng/mL
Standard Deviation 48.248
|
151.1 ng/mL
Standard Deviation 64.913
|
—
|
PRIMARY outcome
Timeframe: 5 hours (post dose) on Day 10Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=6 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
|
62.38 ng/mL
Standard Deviation 31.441
|
59.15 ng/mL
Standard Deviation 33.294
|
—
|
PRIMARY outcome
Timeframe: 24 hours (post dose) on Day 10Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=5 Participants
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).
|
PF-02545920 (Cohort 2)
n=8 Participants
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
|
24.16 ng/mL
Standard Deviation 21.032
|
21.11 ng/mL
Standard Deviation 21.859
|
—
|
PRIMARY outcome
Timeframe: 0 hour (predose) on Day 18Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)
|
42.71 ng/mL
Standard Deviation 24.256
|
—
|
—
|
PRIMARY outcome
Timeframe: 25 minutes (post dose) Day 18Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)
|
156.1 ng/mL
Standard Deviation 92.032
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 hour 30 minutes (post dose) on Day 18Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)
|
156.4 ng/mL
Standard Deviation 53.842
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 hours (post dose) on Day 18Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)
|
61.30 ng/mL
Standard Deviation 23.764
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours (post dose) on Day 18Population: PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.
Outcome measures
| Measure |
PF-02545920 (Cohort 1)
n=12 Participants
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).
|
PF-02545920 (Cohort 2)
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).
|
Placebo (Cohorts 1 and 2)
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
|---|---|---|---|
|
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)
|
20.85 ng/mL
Standard Deviation 13.798
|
—
|
—
|
Adverse Events
PF-02545920 (Cohort 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-02545920 (Cohort 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Cohorts 1 and 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-02545920 (Cohort 3)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo (Cohort 3)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-02545920 (Cohort 1)
n=6 participants at risk
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).
|
PF-02545920 (Cohort 2)
n=8 participants at risk
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).
|
Placebo (Cohorts 1 and 2)
n=7 participants at risk
Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days.
|
PF-02545920 (Cohort 3)
n=14 participants at risk
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).
|
Placebo (Cohort 3)
n=2 participants at risk
Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days.
|
|---|---|---|---|---|---|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/6 • 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.
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.
|
12.5%
1/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
14.3%
1/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
14.3%
1/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
14.3%
1/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Akathisia
|
16.7%
1/6 • 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.
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.
|
37.5%
3/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
21.4%
3/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • 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.
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.
|
12.5%
1/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Dystonia
|
16.7%
1/6 • 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.
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.
|
25.0%
2/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Extrapyramidal disorder
|
16.7%
1/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
21.4%
3/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
28.6%
4/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Oromandibular dystonia
|
16.7%
1/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
50.0%
1/2 • 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.
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.
|
|
Nervous system disorders
Somnolence
|
83.3%
5/6 • 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.
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.
|
37.5%
3/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
50.0%
7/14 • 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.
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.
|
50.0%
1/2 • 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.
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.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
14.3%
1/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
14.3%
2/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 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.
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.
|
12.5%
1/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
0.00%
0/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
0.00%
0/2 • 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.
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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • 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.
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.
|
0.00%
0/8 • 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.
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.
|
0.00%
0/7 • 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.
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.
|
7.1%
1/14 • 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.
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.
|
50.0%
1/2 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER