Trial Outcomes & Findings for Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo (NCT NCT00570063)

Last Updated: 2017-12-20

Results Overview

PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Baseline (Day 1), Day 21

Results posted on

2017-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	PF-02545920 15 Milligram (mg) Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Overall Study STARTED	24	11
Overall Study COMPLETED	9	3
Overall Study NOT COMPLETED	15	8

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-02545920 15 Milligram (mg) Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Overall Study Adverse Event	4	1
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	4	3
Overall Study Sponsor's Decision	7	3

Baseline Characteristics

Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Total n=35 Participants Total of all reporting groups
Age, Continuous	42.3 years STANDARD_DEVIATION 9.3 • n=5 Participants	43.1 years STANDARD_DEVIATION 10.8 • n=7 Participants	42.6 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: Pharmacodynamic data (PD) analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score Baseline	98.13 units on a scale Standard Deviation 12.28	96.10 units on a scale Standard Deviation 4.61
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score Change at Day 21	-19.82 units on a scale Standard Deviation 19.06	-18.25 units on a scale Standard Deviation 24.09

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score Baseline	26.13 units on a scale Standard Deviation 3.31	26.50 units on a scale Standard Deviation 2.17
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score Change at Day 21	-5.55 units on a scale Standard Deviation 4.87	-4.50 units on a scale Standard Deviation 7.55

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=10 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score Baseline	24.17 units on a scale Standard Deviation 5.31	20.90 units on a scale Standard Deviation 3.54
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score Change at Day 21	-5.91 units on a scale Standard Deviation 5.86	-4.50 units on a scale Standard Deviation 7.85

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology). PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score Baseline	47.83 units on a scale Standard Deviation 6.88	48.70 units on a scale Standard Deviation 3.59
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score Change at Day 21	-8.36 units on a scale Standard Deviation 10.04	-9.25 units on a scale Standard Deviation 9.78

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score Baseline	30.04 units on a scale Standard Deviation 3.47	29.20 units on a scale Standard Deviation 2.35
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score Change at Day 21	-6.18 units on a scale Standard Deviation 5.67	-3.50 units on a scale Standard Deviation 9.15

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score Baseline	22.63 units on a scale Standard Deviation 5.50	20.30 units on a scale Standard Deviation 4.11
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score Change at Day 21	-6.27 units on a scale Standard Deviation 5.83	-5.75 units on a scale Standard Deviation 8.30

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score Baseline	22.92 units on a scale Standard Deviation 5.42	21.50 units on a scale Standard Deviation 3.41
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score Change at Day 21	-4.18 units on a scale Standard Deviation 5.10	-3.50 units on a scale Standard Deviation 4.80

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score Baseline	9.33 units on a scale Standard Deviation 3.58	10.80 units on a scale Standard Deviation 3.05
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score Change at Day 21	-0.45 units on a scale Standard Deviation 3.11	-1.25 units on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score Baseline	13.21 units on a scale Standard Deviation 2.34	14.30 units on a scale Standard Deviation 2.75
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score Change at Day 21	-2.73 units on a scale Standard Deviation 3.64	-4.25 units on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia. The scale consists of 18 items. Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe). BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score Baseline	17.17 units on a scale Standard Deviation 2.35	17.60 units on a scale Standard Deviation 1.65
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score Change at Day 21	-3.55 units on a scale Standard Deviation 3.24	-4.25 units on a scale Standard Deviation 5.50

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia. Score range: 1 (normal - not ill at all) to 7 (most extreme illness). Higher score indicating greater degree of illness.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 Change at Day 21	-0.91 units on a scale Standard Deviation 0.701	-1 units on a scale Standard Deviation 1.414
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 Baseline	4.88 units on a scale Standard Deviation 0.448	4.9 units on a scale Standard Deviation 0.568

SECONDARY outcome

Timeframe: Baseline (Day 4), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse). Higher score indicating less improvement.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 Baseline	3.3 units on a scale Standard Deviation 0.93	3.6 units on a scale Standard Deviation 0.52
Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 Change at Day 21	3.09 units on a scale Standard Deviation 1.51	3 units on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

NOSIE is an inpatient treatment staff-administered questionnaire. It consists of 30 items: 26 items divided into 6 subscales and 4 individual items. Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants. 6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4). For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=19 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=9 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Cried	0.26 units on a scale Standard Deviation 0.933	0.22 units on a scale Standard Deviation 0.441
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Cried	-0.16 units on a scale Standard Deviation 0.958	0 units on a scale Standard Deviation 0.5
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Felt blue or depressed	0.63 units on a scale Standard Deviation 0.761	1.11 units on a scale Standard Deviation 1.269
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Felt blue or depressed	0 units on a scale Standard Deviation 0.882	-0.44 units on a scale Standard Deviation 1.424
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Irritability	2.47 units on a scale Standard Deviation 2.611	3.67 units on a scale Standard Deviation 5.958
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Irritability	1.21 units on a scale Standard Deviation 4.063	-0.33 units on a scale Standard Deviation 4.848
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Manifest psychosis	2.37 units on a scale Standard Deviation 2.314	3.78 units on a scale Standard Deviation 3.27
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Manifest psychosis	-0.32 units on a scale Standard Deviation 2.868	-0.89 units on a scale Standard Deviation 3.14
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Personal neatness	11.95 units on a scale Standard Deviation 3.535	11.11 units on a scale Standard Deviation 4.256
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Personal neatness	0 units on a scale Standard Deviation 2.236	-0.56 units on a scale Standard Deviation 1.74
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Refused to speak	0.32 units on a scale Standard Deviation 0.582	0 units on a scale Standard Deviation 0
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Refused to speak	-0.11 units on a scale Standard Deviation 0.567	0.22 units on a scale Standard Deviation 0.441
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Retardation	4.05 units on a scale Standard Deviation 2.527	3.67 units on a scale Standard Deviation 1.323
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Retardation	-0.63 units on a scale Standard Deviation 3.077	0 units on a scale Standard Deviation 1.803
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Said he/she was no good	0.26 units on a scale Standard Deviation 0.452	0.22 units on a scale Standard Deviation 0.441
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Said he/she was no good	0.05 units on a scale Standard Deviation 0.621	0.22 units on a scale Standard Deviation 0.441
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Social competence	17.37 units on a scale Standard Deviation 3.847	17.44 units on a scale Standard Deviation 2.242
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Social competence	0.11 units on a scale Standard Deviation 2.233	0.67 units on a scale Standard Deviation 3.354
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Baseline: Social interest	6.84 units on a scale Standard Deviation 3.516	8.89 units on a scale Standard Deviation 2.522
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 Change at Day 21: Social interest	1.16 units on a scale Standard Deviation 3.775	1.78 units on a scale Standard Deviation 5.674

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 21

Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.

GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning. It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=22 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=9 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 Baseline	41.18 units on a scale Standard Deviation 10.285	40.78 units on a scale Standard Deviation 9.497
Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 Change at Day 21	8.05 units on a scale Standard Deviation 12.786	2.33 units on a scale Standard Deviation 10.677

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 31

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

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse event	22 participants	9 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious adverse event	5 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 31

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

Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (\<) 40 or greater than (\>) 120 beats per minute (bpm), pulse rate in standing position \<40 or \>140 bpm; systolic blood pressure (SBP) \<90 millimeters of mercury (mm Hg) and greater than or equal to (\>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) \<50 mm Hg and \>=20 mm Hg change (increase, decrease) from baseline in same posture.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Vital Signs of Potential Clinical Concern Supine pulse rate <40 bpm	0 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Supine pulse rate >120 bpm	0 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Standing pulse rate <40 bpm	0 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Standing pulse rate >140 bpm	3 participants	2 participants
Number of Participants With Vital Signs of Potential Clinical Concern Supine SBP <90 mm Hg	0 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Standing SBP <90 mm Hg	1 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Increase from baseline in supine SBP >=30 mm Hg	0 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Increase from baseline in standing SBP >=30 mm Hg	1 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Decrease from baseline in supine SBP >=30 mm Hg	3 participants	3 participants
Number of Participants With Vital Signs of Potential Clinical Concern Decrease from baseline in standing SBP >=30 mm Hg	2 participants	1 participants
Number of Participants With Vital Signs of Potential Clinical Concern Supine DBP <50 mm Hg	1 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Standing DBP <50 mm Hg	1 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Increase from baseline in supine DBP >=20 mm Hg	2 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Increase from baseline in standing DBP >=20 mm Hg	4 participants	0 participants
Number of Participants With Vital Signs of Potential Clinical Concern Decrease from baseline in supine DBP >=20 mm Hg	8 participants	2 participants
Number of Participants With Vital Signs of Potential Clinical Concern Decrease from baseline in standing DBP >=20 mm Hg	4 participants	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 31

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

Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems. Clinical significance was based on the investigator's discretion.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities Physical examination	0 participants	0 participants
Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities Neurological examination	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 31

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

Criteria for ECG values for potential clinical concern: PR interval \>=300 millisecond (msec), \>=25 percent increase when baseline \>200 msec, and \>=50 percent increase when baseline less than or equal to (\<=) 200 msec; QRS interval \>=200 msec, \>=25 percent increase when baseline \>100 msec, and \>=50 percent increase when baseline \<=100 msec; QTcB interval (corrected QT interval using Bazett's formula) \>=500 msec.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 31

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

Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: \<0.8\*lower limit of normal (LLN), platelet: \<0.5\*LLN or \>1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN or \>1.5\*ULN, lymphocyte, neutrophil: \<0.8\*LLN or \>1.2\*ULN, basophil, eosinophil, monocyte: \>1.2\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: \> 3.0\*ULN, total protein, albumin: \<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine: \>1.3\*ULN, uric acid \>1.2\*ULN; cholesterol (HDL \<0.8\*LLN, LDL \>1.2\*ULN); sodium \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN or \>1.1\*ULN, phosphate \<0.8\*LLN or \>1.2\*ULN; prolactin \>1.1\*ULN; glucose \<0.6\*LLN or \>1.5\*ULN, glycosylated hemoglobin \>1.3\*ULN, creatine kinase \>2.0\*ULN; urine (pH \<4.5 or \>8, glucose, ketone, protein, blood/Hgb \>=1, RBC, WBC \>=6).

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=10 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Laboratory Abnormalities	18 participants	8 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 21

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

Number of participants with abnormal values (\>1.1\* ULN) of prolactin level were reported.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=22 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=9 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Abnormal Prolactin Level	2 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Day 21

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

Number of participants with abnormal values of HDL level \<0.8\* LLN and LDL level \>1.2\*ULN were reported.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=10 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level HDL <0.8*LLN	0 participants	1 participants
Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level LDL >1.2*ULN	3 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 21

Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this measure.

Number of participants with abnormal values (\>1.3\* ULN) of HbA1c level were reported.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=22 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=10 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level	3 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Day 21

Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this outcome measure.

Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal. Number of participants with abnormal values of fasting insulin level were reported.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=10 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Number of Participants With Abnormal Fasting Insulin Level	13 participants	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Day 21

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

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Body Weight at Day 21 Baseline	87.48 kilogram Standard Deviation 28.977	85.82 kilogram Standard Deviation 16.969
Change From Baseline in Body Weight at Day 21 Change at Day 21	-1.07 kilogram Standard Deviation 4.468	-0.22 kilogram Standard Deviation 3.567

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Day 21

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

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Abdominal Girth at Day 21 Baseline	86.57 centimeter Standard Deviation 19.654	90.15 centimeter Standard Deviation 14.87
Change From Baseline in Abdominal Girth at Day 21 Change at Day 21	1.64 centimeter Standard Deviation 6.701	5.83 centimeter Standard Deviation 13.818

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Day 21

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

ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions). It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia. Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Baseline: Parkinsonism	2.5 units on a scale Standard Deviation 2.919	1.7 units on a scale Standard Deviation 2.058
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Change at Day 21: Parkinsonism	-0.27 units on a scale Standard Deviation 3.952	0 units on a scale Standard Deviation 0.816
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Baseline: Dyskinesia	0.58 units on a scale Standard Deviation 1.472	0.6 units on a scale Standard Deviation 1.075
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Change at Day 21: Dyskinesia	0.82 units on a scale Standard Deviation 3.371	1 units on a scale Standard Deviation 1.155
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Baseline: Dystonia	0.29 units on a scale Standard Deviation 1.083	0.3 units on a scale Standard Deviation 0.675
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Change at Day 21: Dystonia	-0.18 units on a scale Standard Deviation 1.401	0.75 units on a scale Standard Deviation 1.5
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Baseline: Akathisia	0.54 units on a scale Standard Deviation 1.215	0.7 units on a scale Standard Deviation 1.337
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 Change at Day 21: Akathisia	0.45 units on a scale Standard Deviation 1.864	-0.25 units on a scale Standard Deviation 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Day 4, 7, 14, 21

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

SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake. Score ranging from 1 to 7, where higher score indicates more sleepiness.

Outcome measures

Outcome measures
Measure	PF-02545920 15 Milligram (mg) n=24 Participants Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 Participants Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 Baseline	2.3 units on a scale Standard Deviation 0.926	2 units on a scale Standard Deviation 1.054
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 Change at Day 4	-0.09 units on a scale Standard Deviation 1.019	0.2 units on a scale Standard Deviation 1.549
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 Change at Day 7	0.11 units on a scale Standard Deviation 1.243	-0.22 units on a scale Standard Deviation 1.563
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 Change at Day 14	-0.23 units on a scale Standard Deviation 1.536	-0.67 units on a scale Standard Deviation 1.211
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 Change at Day 21	-0.4 units on a scale Standard Deviation 1.075	-0.5 units on a scale Standard Deviation 1.291

OTHER_PRE_SPECIFIED outcome

Timeframe: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21

Population: Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient pharmacokinetic (PK) sampling to support development of a model to calculate the PK parameters.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21

Population: Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21

Population: Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.

Outcome measures

Outcome data not reported

Adverse Events

PF-02545920 15 Milligram (mg)

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-02545920 15 Milligram (mg) n=24 participants at risk Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.	Placebo n=11 participants at risk Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
Blood and lymphatic system disorders Neutropenia	4.2% 1/24 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	4.2% 1/24 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dystonia	4.2% 1/24 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Psychotic disorder	4.2% 1/24 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Schizophrenia	4.2% 1/24 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

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