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

A Phase 1 study testing PF-02545920 in people with Schizophrenia, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Schizophrenia
What is being tested?: PF-02545920
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 6 Mar 2013to 17 Oct 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

California Clinical Trials Medical Group
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Adjunctive Safety, Tolerability And Pharmacokinetics Of Pf-02545920 In Psychiatrically Stable Subjects With Schizophrenia

Conditions: Schizophrenia
Being tested: PF-02545920, Placebo
Keywords: PF-02545920, safety, schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-02545920Drug
Also called Cohort 1
15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h
PF-02545920Drug
Also called Cohort 2
15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h
PF-02545920Drug
Also called Cohort 3
15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h
PlaceboDrug
Placebo Q12h

Study groups in NCT01829048
Study group	Role	What they receive
PF-02545920	Experimental	Not described Receives: Drug: PF-02545920
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
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.
Measured: Day 0 (Baseline) up to Day 10
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
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.
Measured: Day 0 (Baseline) up to Day 18
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
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.
Measured: Day 0 (Baseline)
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
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.
Measured: Day 11
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
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.
Measured: Follow-up (any day between Day 17 and 20)
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
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.
Measured: Day 0 (Baseline)
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
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.
Measured: Day 19
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
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.
Measured: Follow-up (any day between Day 26 and 29)
Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)
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.
Measured: Screening up to Follow-up (any day between Day 17 and 20)
Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)
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.
Measured: Screening up to Follow-up (any day between Day 26 and 29)
Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)
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.
Measured: Day 0 up to Follow-up (any day between Day 17 and 20)
Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)
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.
Measured: Day 0 up to Follow-up (any day between Day 26 and 29)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)
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.
Measured: The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)
Number of Participants With TEAEs (Cohort 3)
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.
Measured: The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)
Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Measured: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Measured: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
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.
Measured: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
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.
Measured: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
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).
Measured: Day 0 (Baseline) up to Day 10
Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
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).
Measured: Screening up to Day 18
Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)
Measured: 0 hour (predose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
Measured: 25 minutes (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
Measured: 1 hour 30 minutes (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
Measured: 5 hours (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
Measured: 24 hours (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)
Measured: 0 hour (predose) on Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)
Measured: 25 minutes (post dose) Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)
Measured: 1 hour 30 minutes (post dose) on Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)
Measured: 5 hours (post dose) on Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)
Measured: 24 hours (post dose) on Day 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201317 Oct 2013

First posted11 Apr 2013 (estimated)
Study start6 Mar 2013
Primary completion17 Oct 2013
Study completion17 Oct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01829048
Sponsor's protocol ID: A8241018
Status last verified: Nov 2017
First submitted: 6 Mar 2013
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Adjunctive Safety, Tolerability And Pharmacokinetics Of Pf-02545920 In Psychiatrically Stable Subjects With Schizophrenia
ClinicalTrials.gov ID: NCT01829048
Acronym / sponsor ID: A8241018
Conditions: Schizophrenia
Keywords: PF-02545920, safety, schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 6 Mar 2013 (actual)
Primary completion: 17 Oct 2013 (actual)
Study completion: 17 Oct 2013 (actual)
First posted: 11 Apr 2013 (estimated)
Results: Posted 20 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PF-02545920	Experimental	Drug: PF-02545920
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-02545920Also: Cohort 115 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h	Drug	PF-02545920
PF-02545920Also: Cohort 215 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h	Drug	PF-02545920
PF-02545920Also: Cohort 315 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h	Drug	PF-02545920
PlaceboPlacebo Q12h	Drug	Placebo

Primary outcome

Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10
Time frame: Day 0 (Baseline) up to Day 10
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.
Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18
Time frame: Day 0 (Baseline) up to Day 18
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.
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)
Time frame: Day 0 (Baseline)
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.
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11
Time frame: Day 11
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.
Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)
Time frame: Follow-up (any day between Day 17 and 20)
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.
Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)
Time frame: Day 0 (Baseline)
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.
Number of Participants With Response to C-SSRS (Cohort 3) at Day 19
Time frame: Day 19
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.
Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)
Time frame: Follow-up (any day between Day 26 and 29)
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.
Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)
Time frame: Screening up to Follow-up (any day between Day 17 and 20)
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.
Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)
Time frame: Screening up to Follow-up (any day between Day 26 and 29)
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.
Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)
Time frame: Day 0 up to Follow-up (any day between Day 17 and 20)
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.
Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)
Time frame: Day 0 up to Follow-up (any day between Day 26 and 29)
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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)
Time frame: The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)
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.
Number of Participants With TEAEs (Cohort 3)
Time frame: The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)
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.
Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)
Time frame: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)
Time frame: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Time frame: Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)
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.
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Time frame: Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)
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.
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)
Time frame: Day 0 (Baseline) up to Day 10
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).
Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)
Time frame: Screening up to Day 18
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).
Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)
Time frame: 0 hour (predose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
Time frame: 25 minutes (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)
Time frame: 1 hour 30 minutes (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
Time frame: 5 hours (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)
Time frame: 24 hours (post dose) on Day 10
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)
Time frame: 0 hour (predose) on Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)
Time frame: 25 minutes (post dose) Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)
Time frame: 1 hour 30 minutes (post dose) on Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)
Time frame: 5 hours (post dose) on Day 18
Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)
Time frame: 24 hours (post dose) on Day 18

Results and safety

Results posted to the registry on 20 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-02545920 (Cohort 1)	6	6
PF-02545920 (Cohort 2)	8	8
Placebo (Cohorts 1 and 2)	7	7
PF-02545920 (Cohort 3)	14	12
Placebo (Cohort 3)	2	2

Primary outcome: Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10

Time frame: Day 0 (Baseline) up to Day 10. Mean (Standard Deviation). Unit: Units on a scale

Measure	PF-02545920 (Cohort 1) n = 6	PF-02545920 (Cohort 2) n = 8	Placebo (Cohorts 1 and 2) n = 7
ESRS-A Parkinsonism	-0.2 (1.60)	-0.3 (0.46)	0.1 (1.21)
ESRS-A Dystonia	0.0 (0.00)	0.0 (0.00)	-0.1 (0.38)
ESRS-A Dyskinesia	0.0 (0.00)	0.0 (0.00)	-0.1 (0.38)
ESRS-A Akathisia	0.0 (0.00)	0.5 (0.93)	0.0 (0.00)
CGI-S Parkinsonism	0.0 (0.63)	0.0 (0.00)	0.0 (0.58)
CGI-S Dystonia	0.0 (0.00)	0.0 (0.00)	-0.1 (0.38)
CGI-S Dyskinesia	0.0 (0.00)	0.0 (0.00)	-0.1 (0.38)
CGI-S Akathisia	0.0 (0.00)	0.1 (0.35)	0.0 (0.00)

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication.

Primary outcome: Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18

Time frame: Day 0 (Baseline) up to Day 18. Mean (Standard Deviation). Unit: Units on a scale

Measure	PF-02545920 (Cohort 3) n = 12	Placebo (Cohort 3) n = 2
ESRS-A Parkinsonism	0.3 (1.50)	0.0 (0.00)
ESRS-A Dystonia	0.0 (0.00)	0.0 (0.00)
ESRS-A Dyskinesia	0.0 (0.00)	0.0 (0.00)
ESRS-A Akathisia	0.6 (1.38)	0.0 (0.00)
CGI-S Parkinsonism	0.2 (0.58)	0.0 (0.00)
CGI-S Dystonia	0.0 (0.00)	0.0 (0.00)
CGI-S Dyskinesia	0.0 (0.00)	0.0 (0.00)
CGI-S Akathisia	0.3 (0.78)	0.0 (0.00)

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.

Primary outcome: Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)

Time frame: Day 0 (Baseline). Number. Unit: Participants

Measure	PF-02545920 (Cohort 1) n = 6	PF-02545920 (Cohort 2) n = 8	Placebo (Cohorts 1 and 2) n = 7
C-CASA Event Code 1	0	0	0
C-CASA Event Code 2	0	0	0
C-CASA Event Code 3	0	0	0
C-CASA Event Code 4	0	0	0
C-CASA Event Code 7	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11

Time frame: Day 11. Number. Unit: Participants

Measure	PF-02545920 (Cohort 1) n = 5	PF-02545920 (Cohort 2) n = 8	Placebo (Cohorts 1 and 2) n = 6
C-CASA Event Code 1	0	0	0
C-CASA Event Code 2	0	0	0
C-CASA Event Code 3	0	0	0
C-CASA Event Code 4	0	0	0
C-CASA Event Code 7	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.

Adverse events

Time frame: From the time the subject had taken at least 1 dose of study treatment through last subject visit. For serious AEs (SAEs), the time began from the subject provided informed consent through 28 calendar days post last administration of study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-02545920 (Cohort 1)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
PF-02545920 (Cohort 2)	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Placebo (Cohorts 1 and 2)	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
PF-02545920 (Cohort 3)	0 of 14 (0%)	9 of 14 (64.3%)	Not reported
Placebo (Cohort 3)	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-02545920 in people with Schizophrenia, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10 (time frame: Day 0 (Baseline) up to Day 10). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01829048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.