SchizophreniaPhase 1NCT02418819

A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia

A Phase 1 study testing PF-06412562 3mg BID, PF-06412562 9mg BID and PF-06412562 45mg BID in people with Schizophrenia, run by Pfizer at 6 sites in United States.

Completed

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

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Schizophrenia
What is being tested?: PF-06412562 3mg BID, PF-06412562 9mg BID and PF-06412562 45mg BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 6 sitesUnited States
Study dates: Apr 2015to Oct 2016
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects with schizophrenia both male and female
Evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc).
Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to Day 1, including concomitant psychotropic medications.

Who cannot join

History of seizure
Pregnant or nursing females
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Arcadia MRI & Imaging Center
Arcadia, California, 91007
Maryland Psychiatric Research Center (MPRC) of the University of Maryland
Baltimore, Maryland, 21228
CBH Health, LLC
Gaithersburg, Maryland, 20877
California Clinical Trials Medical Group
Glendale, California, 91206
Glendale Adventist Medical Center
Glendale, California, 91206
Foers Long Term Care Pharmacy LLC
Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, SPONSOR OPEN, PHASE 1B STUDY TO EXAMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-06412562 IN PSYCHIATRICALLY STABLE SUBJECTS WITH SCHIZOPHRENIA

Read the detailed description

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.

Conditions: Schizophrenia
Being tested: PF-06412562 3mg BID, PF-06412562 9mg BID, PF-06412562 45mg BID, Placebo
Medical subject headings: Schizophrenia

What participants receive

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

PF-06412562 3mg BIDDrug
Also called PF-06412562 3mg
PF-06412562
PF-06412562 9mg BIDDrug
Also called PF-06412562 9mg
PF-06412562
PF-06412562 45mg BIDDrug
Also called PF-06412562 45mg
PF-06412562
PlaceboOther
Placebo

Study groups in NCT02418819
Study group	Role	What they receive
PF-06412562 3mg	Experimental	PF-06412562 3mg BID Receives: Drug: PF-06412562 3mg BID
PF-06412562 9mg	Experimental	PF-06412562 9mg BID Receives: Drug: PF-06412562 9mg BID
PF-06412562 45mg	Experimental	PF-06412562 45mg BID Receives: Drug: PF-06412562 45mg BID
Placebo	Placebo comparator	Placebo BID Receives: Other: Placebo

What is being measured

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

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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 15

Secondary outcomes (2)

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.
Measured: 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.
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.
Measured: 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day16

Timeline

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

Apr 2015Oct 2016

First posted16 Apr 2015 (estimated)
Study startApr 2015
Primary completionOct 2016
Study completionOct 2016

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.
Publications (1)Papers the sponsor has linked to this study.
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
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02418819
Sponsor's protocol ID: B7441007
Status last verified: Jan 2019
First submitted: 23 Mar 2015
Last updated: 4 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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.

Publications

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.
PubMed 31264510

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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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, SPONSOR OPEN, PHASE 1B STUDY TO EXAMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-06412562 IN PSYCHIATRICALLY STABLE SUBJECTS WITH SCHIZOPHRENIA
ClinicalTrials.gov ID: NCT02418819
Acronym / sponsor ID: B7441007
Conditions: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2015 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 16 Apr 2015 (estimated)
Results: Posted 4 Feb 2019

Clinical summary

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

Detailed description

All doses will be administered twice daily, with approximately 12 hours between each dose.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
PF-06412562 3mg	Experimental	Drug: PF-06412562 3mg BIDPF-06412562 3mg BID
PF-06412562 9mg	Experimental	Drug: PF-06412562 9mg BIDPF-06412562 9mg BID
PF-06412562 45mg	Experimental	Drug: PF-06412562 45mg BIDPF-06412562 45mg BID
Placebo	Placebo comparator	Other: PlaceboPlacebo BID

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Subjects with schizophrenia both male and female
Evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc).
Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to Day 1, including concomitant psychotropic medications.

Key exclusion criteria (3 listed)

History of seizure
Pregnant or nursing females
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).

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-06412562 3mg BIDAlso: PF-06412562 3mgPF-06412562	Drug	PF-06412562 3mg
PF-06412562 9mg BIDAlso: PF-06412562 9mgPF-06412562	Drug	PF-06412562 9mg
PF-06412562 45mg BIDAlso: PF-06412562 45mgPF-06412562	Drug	PF-06412562 45mg
PlaceboPlacebo	Other	Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days
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.
Number of Participants With Supine and Standing Vital Signs Meeting Categorical Summarization Criteria
Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days
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).
Number of Participants With Electrocardiogram (ECG) (Standard 12-Lead) Data Meeting Categorical Summarization Criteria
Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days
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
Number of Participants With Blood and Urine Safety Laboratory Test Abnormalities
Time frame: Baseline up to Day 15
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.
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.
Time frame: Baseline, Days 1,7 and follow-up (7-10 days after last dose of study drug, up to 26 days)
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.
Change From Baseline to Day 13 of Wechsler Memory Scale (WMS III) Spatial Span + Letter Number Span Composite Score (Working Memory Domain)
Time frame: Baseline, Day 13
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.
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
Time frame: Baseline, 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.

2 secondary outcomes

Plasma Concentrations of PF-06412562 for Each Dose.
Time frame: 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.
Time frame: 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day16

Results and safety

Results posted to the registry on 4 Feb 2019, 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-06412562 3 mg BID	22	21
PF-06412562 9 mg BID	16	16
PF-06412562 45 mg BID	33	29
Placebo	29	28

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days. Count of participants. Unit: Participants

Measure	PF-06412562 3 mg BID n = 22	PF-06412562 9 mg BID n = 16	PF-06412562 45 mg BID n = 33	Placebo n = 29
AEs	10	10	17	14
SAEs	1	0	0	0

Population analysed: The safety analysis set was used, defined as all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Supine and Standing Vital Signs Meeting Categorical Summarization Criteria

Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days. Count of participants. Unit: Participants

Measure	PF-06412562 3 mg BID n = 22	PF-06412562 9 mg BID n = 16	PF-06412562 45 mg BID n = 33	Placebo n = 29
Supine SBP <90 mm Hg	1	3	6	6
Standing SBP <90 mm Hg	1	0	1	1
Supine DBP <50 mm Hg	0	2	2	2
Standing DBP <50 mm Hg	0	0	0	0
Supine Pulse rate <40 bpm	0	0	0	0
Supine Pulse rate >120 bpm	0	0	0	0
Standing Pulse rate <40 bpm	0	0	0	0
Standing Pulse rate >140 bpm	0	0	0	0

Population analysed: The safety analysis set was used, which defined as all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Electrocardiogram (ECG) (Standard 12-Lead) Data Meeting Categorical Summarization Criteria

Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days. Count of participants. Unit: Participants

Measure	PF-06412562 3 mg BID n = 22	PF-06412562 9 mg BID n = 16	PF-06412562 45 mg BID n = 33	Placebo n = 29
PR interval >=300 msec	0	0	0	0
QRS complex >=200 msec	0	0	0	0
QTcF interval 450-480 msec	0	0	1	0
QTcF interval 480-500 msec	0	0	0	0
QTcF interval >=500 msec	0	0	0	0
PR interval increase b>200 & PChg>=25%	0	0	0	0
PR interval increase b<=200 & PChg>=50%	0	0	0	0
QRS complex increase b>100 & PChg>=25%	0	0	0	0

Population analysed: The safety analysis set was used, defined as all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Blood and Urine Safety Laboratory Test Abnormalities

Time frame: Baseline up to Day 15. Count of participants. Unit: Participants

Measure	PF-06412562 3 mg BID n = 22	PF-06412562 9 mg BID n = 16	PF-06412562 45 mg BID n = 29	Placebo n = 28
Value	9	8	8	12

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06412562 3 mg BID	1 of 22 (4.5%)	7 of 22 (31.8%)	Not reported
PF-06412562 9 mg BID	0 of 16 (0%)	10 of 16 (62.5%)	Not reported
PF-06412562 45 mg BID	0 of 33 (0%)	17 of 33 (51.5%)	Not reported
Placebo	0 of 29 (0%)	12 of 29 (41.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31264510Arce 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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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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

6 sites 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-06412562 3mg BID, PF-06412562 9mg BID and PF-06412562 45mg BID in people with Schizophrenia, run by Pfizer at 6 sites 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 4 Feb 2019). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to 7-10 days after last dose of study drug, up to 26 days). The study lists 7 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 NCT02418819, which also lists 1 linked publication.

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 4 Feb 2019.