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This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.
B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of 3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100 psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with schizophrenia are on background treatment with SOC antipsychotics and other psychotropic medications.
All doses will be administered twice daily, with approximately 12 hours between each dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06412562 3mg | Experimental | PF-06412562 3mg BID |
|
| PF-06412562 9mg | Experimental | PF-06412562 9mg BID |
|
| PF-06412562 45mg | Experimental | PF-06412562 45mg BID |
|
| Placebo | Placebo Comparator | Placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06412562 3mg BID | Drug | PF-06412562 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. AEs included both serious and non-serious AEs. | Baseline up to 7-10 days after last dose of study drug, up to 26 days |
| Number of Participants With Supine and Standing Vital Signs Meeting Categorical Summarization Criteria | Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm). | Baseline up to 7-10 days after last dose of study drug, up to 26 days |
| Number of Participants With Electrocardiogram (ECG) (Standard 12-Lead) Data Meeting Categorical Summarization Criteria | ECG categorical summarization criteria were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): more than or equal to (>=) 200 milliseconds (msec); for percent change(PChg), >=25 percent (%) increase when baseline (b)>100 msec; or increase >=50% when b less than or equal to (<=)100 msec; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25percent (%) increase when b >200 msec; or increase >=50% when b <=200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec and >=500 msec; increase from b >=30 - <60 and >=60 msec |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of PF-06412562 for Each Dose. | PF-06412562 plasma concentration for each dose at 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16. | 6, and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16 |
| Plasma Concentrations of PF-06663872 at for Each Dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcadia MRI & Imaging Center | Arcadia | California | 91007 | United States | ||
| California Clinical Trials Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31264510 | Derived | Arce E, Balice-Gordon R, Duvvuri S, Naylor M, Xie Z, Harel B, Kozak R, Gray DL, DeMartinis N. A novel approach to evaluate the pharmacodynamics of a selective dopamine D1/D5 receptor partial agonist (PF-06412562) in patients with stable schizophrenia. J Psychopharmacol. 2019 Oct;33(10):1237-1247. doi: 10.1177/0269881119855302. Epub 2019 Jul 2. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 103 participants were randomized and assigned to study treatment. One (1) participant in the PF-06412562 3 mg twice a day (BID) group and 2 participants in the PF-06412562 45 mg BID group did not receive study drug. Therefore, 100 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06412562 3 mg BID | Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| FG001 | PF-06412562 9 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-06412562 9mg BID | Drug | PF-06412562 |
|
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| PF-06412562 45mg BID | Drug | PF-06412562 |
|
|
| Placebo | Other | Placebo |
|
| Baseline up to 7-10 days after last dose of study drug, up to 26 days |
| Number of Participants With Blood and Urine Safety Laboratory Test Abnormalities | The total number of participants with blood and urine laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests. | Baseline up to Day 15 |
| Number of Participants With New Onset and Worsening of Post Baseline Suicidality in Columbia Suicide Severity Rating Scale (C-SSRS) on Day 1, Day 7 and Follow-up. | The C-SSRS was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. Versions were available for Screening/Baseline and follow-up visits. Post-baseline suicidality was displayed without regard to baseline and as new onset or worsening relative to baseline. A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment. A participant was considered to have a worsening of suicidality if the participant moved to a lower numbered Columbia Classification Algorithm of Suicide Assessment (C-CASA) category (observed in categories 1-4) than was reported at baseline. | Baseline, Days 1,7 and follow-up (7-10 days after last dose of study drug, up to 26 days) |
| Change From Baseline to Day 13 of Wechsler Memory Scale (WMS III) Spatial Span + Letter Number Span Composite Score (Working Memory Domain) | MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. Total score range of this subset ranges from 40 (minimum score) to 60 (maximum score), with higher scores indicating better cognitive function. | Baseline, Day 13 |
| Change From Baseline in Blood Oxygen Level Dependent (BOLD) fMRI Activation Parameter Estimates (Z-scores) in Anterior Ventral Striatum Region of Interest (ROI) for the Contrast of Cue Gain > Cue No Gain in Monetary Incentive Delay (MID) Task on Day 15 | MRI parameter estimates refer to the 90th percentile Z-statistics across all voxels within the Region of Interest (ROI). This task provided a measure of reward anticipation and reward consummation. One of 3 shapes was presented on the screen (each uniquely associated with gain, loss and neutral) as a cue, and participants were instructed to respond to each cue, using their dominant hand, by pressing in response to a subsequent target that appeared for a variable length of time. Baseline was defined as Day 0 assessment. To be included in analysis participants must have complete Monetary Incentive Delay (MID) data at both Baseline and post-baseline, without excessive head motion. Participants with MID <40% at baseline were excluded from the analysis and summary statistics. Scores were not bounded by a minimum or maximum range, higher z-score implies a greater motivation of the participant by the prospect of monetary gain than no monetary gain. | Baseline, Day 15 |
PF-06412562 plasma concentration for each dose at times 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16. |
| 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day16 |
| Glendale |
| California |
| 91206 |
| United States |
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
| Maryland Psychiatric Research Center (MPRC) of the University of Maryland | Baltimore | Maryland | 21228 | United States |
| CBH Health, LLC | Gaithersburg | Maryland | 20877 | United States |
| Foers Long Term Care Pharmacy LLC | Rockville | Maryland | 20850 | United States |
Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose.
| FG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| FG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06412562 3 mg BID | Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| BG001 | PF-06412562 9 mg BID | Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| BG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| BG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. AEs included both serious and non-serious AEs. | The safety analysis set was used, defined as all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 7-10 days after last dose of study drug, up to 26 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Supine and Standing Vital Signs Meeting Categorical Summarization Criteria | Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm). | The safety analysis set was used, which defined as all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 7-10 days after last dose of study drug, up to 26 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Electrocardiogram (ECG) (Standard 12-Lead) Data Meeting Categorical Summarization Criteria | ECG categorical summarization criteria were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): more than or equal to (>=) 200 milliseconds (msec); for percent change(PChg), >=25 percent (%) increase when baseline (b)>100 msec; or increase >=50% when b less than or equal to (<=)100 msec; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25percent (%) increase when b >200 msec; or increase >=50% when b <=200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec and >=500 msec; increase from b >=30 - <60 and >=60 msec | The safety analysis set was used, defined as all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 7-10 days after last dose of study drug, up to 26 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Blood and Urine Safety Laboratory Test Abnormalities | The total number of participants with blood and urine laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests. | The safety analysis set was used, defined as all participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to Day 15 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With New Onset and Worsening of Post Baseline Suicidality in Columbia Suicide Severity Rating Scale (C-SSRS) on Day 1, Day 7 and Follow-up. | The C-SSRS was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. Versions were available for Screening/Baseline and follow-up visits. Post-baseline suicidality was displayed without regard to baseline and as new onset or worsening relative to baseline. A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment. A participant was considered to have a worsening of suicidality if the participant moved to a lower numbered Columbia Classification Algorithm of Suicide Assessment (C-CASA) category (observed in categories 1-4) than was reported at baseline. | The safety analysis set was used, defined as all participants who received at least 1 dose of study medication | Posted | Count of Participants | Participants | Baseline, Days 1,7 and follow-up (7-10 days after last dose of study drug, up to 26 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Day 13 of Wechsler Memory Scale (WMS III) Spatial Span + Letter Number Span Composite Score (Working Memory Domain) | MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. Total score range of this subset ranges from 40 (minimum score) to 60 (maximum score), with higher scores indicating better cognitive function. | Per Protocol Analysis Set (PPAS)subset of Full Analysis Set(FAS).Criteria:1)Received all doses of study treatment to which they randomized2)No major protocol deviation3)Had baseline measurement and at least 1 post baseline measurement for at least 1 PD endpoint.Overall Number of Participants Analyzed=participants evaluable in this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Day 13 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Blood Oxygen Level Dependent (BOLD) fMRI Activation Parameter Estimates (Z-scores) in Anterior Ventral Striatum Region of Interest (ROI) for the Contrast of Cue Gain > Cue No Gain in Monetary Incentive Delay (MID) Task on Day 15 | MRI parameter estimates refer to the 90th percentile Z-statistics across all voxels within the Region of Interest (ROI). This task provided a measure of reward anticipation and reward consummation. One of 3 shapes was presented on the screen (each uniquely associated with gain, loss and neutral) as a cue, and participants were instructed to respond to each cue, using their dominant hand, by pressing in response to a subsequent target that appeared for a variable length of time. Baseline was defined as Day 0 assessment. To be included in analysis participants must have complete Monetary Incentive Delay (MID) data at both Baseline and post-baseline, without excessive head motion. Participants with MID <40% at baseline were excluded from the analysis and summary statistics. Scores were not bounded by a minimum or maximum range, higher z-score implies a greater motivation of the participant by the prospect of monetary gain than no monetary gain. | PPAS was used,defined as subset of FAS dataset.Criteria for PPAS:1)Received all doses of study treatment to which they were randomized;2)No major protocol deviation;3)Had a baseline measurement and at least 1 post baseline measurement for at least 1 PD endpoint.Overall Number of Participants Analyzed=participants evaluable in this outcome measure. | Posted | Mean | Standard Deviation | Z scores | Baseline, Day 15 |
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| Secondary | Plasma Concentrations of PF-06412562 for Each Dose. | PF-06412562 plasma concentration for each dose at 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16. | The PK concentration analysis set was defined as all participants randomized and treated who had at least 1 PK concentration. Here, "number analyzed" signifies the participants evaluable for each time points. | Posted | Mean | Standard Deviation | ng/mL | 6, and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16 |
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| Secondary | Plasma Concentrations of PF-06663872 at for Each Dose. | PF-06412562 plasma concentration for each dose at times 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16. | The PK concentration analysis set was defined as all participants randomized and treated who had at least 1 PK concentration. Here, "number analyzed" signifies the participants evaluable for each time points. | Posted | Mean | Standard Deviation | ng/mL | 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day16 |
|
Baseline up to 7-10 days after last dose of study drug, up to 26 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-06412562 3 mg BID | Participant received 3 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. | 1 | 22 | 7 | 22 | ||
| EG001 | PF-06412562 9 mg BID | Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. | 0 | 16 | 10 | 16 | ||
| EG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. | 0 | 33 | 17 | 33 | ||
| EG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. | 0 | 29 | 12 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C494814 | BID protein, human |
Not provided
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Not provided
| Male |
|
| SAEs |
|
Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| OG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
|
|
Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| OG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| OG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
|
|
| OG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
|
|
| OG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| OG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
|
|
| OG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| OG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
|
|
|
| OG001 | PF-06412562 9 mg BID | Participant received 9 mg PF 06412562 modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
| OG002 | PF-06412562 45 mg BID | Participant received 45 mg PF 06412562 modified release tablets were orally administered twice daily using a titration scheme (15 mg BID for 2 days, 30 mg BID for 2 days and 45 mg BID for the rest of the study) for 15 days with approximately 12 hours between each dose. |
| OG003 | Placebo | Participant received placebo matched to PF 06412562 3 mg and 15 mg modified release tablets were orally administered twice daily for 15 days with approximately 12 hours between each dose. |
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