Idiopathic Parkinson's DiseasePhase 1NCT02565628
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
A Phase 1 study testing PF-06669571 in people with Idiopathic Parkinson's Disease, run by Pfizer at 9 sites in United States.
Trial summary
This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- PF-06669571
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 9 sitesUnited States
- Study dates
- 16 Nov 2015to 13 May 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
- Must be Hoehn \& Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
- Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.
Who cannot join
- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
CTI Clinical Research Center
Cincinnati, Ohio, 45255
MD Clinical
Hallandale, Florida, 33009
QPS-MRA, LLC (Broward Research Group)
Hollywood, Florida, 33024
CRI Worldwide, LLC
Marlton, New Jersey, 08053
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
Qps-Mra Llc
South Miami, Florida, 33143
QPS-MRA, LLC (Miami research Associates)
South Miami, Florida, 33143
QPS-MRA, LLC (MRA Clinical Research)
South Miami, Florida, 33143
About this study
Official title: A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.
This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- PF-06669571, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06669571Drug
1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PF-06669571 | Experimental | Once daily (QD) for 7 days Receives: Drug: PF-06669571 |
| Placebo | Placebo comparator | QD for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7.
The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson's disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson's disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson's disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson's disease. Higher total scores indicate more severe motor signs of Parkinson's disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.
Measured: Day 7
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit
The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act or some intent to act, with specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)
Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.
Number of participants with new onset and worsening of post-baseline suicidality was reported
Measured: Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)
Number of Participants With Treatment Emergent Adverse Events (All Causalities)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Measured: Day 1 to 28 calendar days after the last dose of investigational product
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP <90 millimeters of mercury (mmHg); (2) absolute standing SBP <90 mmHg; (3)absolute supine DBP<50mmHg; (4)absolute standing DBP<50mmHg (5) absolute supine pulse rate <40 beats per minute (bpm); (6) absolute supine pulse rate >120 bpm;(7) absolute standing pulse rate <40 bpm; (8) absolute standing pulse rate >140 bpm.
Measured: Screening, Days -1, 1, 7 and 8, and follow-up visit
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) >=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP >=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) >=20 mmHg
Measured: Screening, Days -1, 1, 7 and 8, and follow-up visit
Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) >=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) >=20 mmHg
Measured: Screening, Days -1, 1, 7 and 8, and follow-up visit
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec
Measured: Screening, Days 1, 7, and 8, and follow-up visit
Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.
Measured: Screening, Days 1, 7, and 8, and follow-up visit
Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).
Measured: Screening, Days 1, 4, and 7, and follow-up visit
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7
Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7
Measured: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7
AUC12 of PF-06669571 refers to the area under the curve from time zero to 12 hours post dose on Day 1 and Day 7. AUC12 was determined by using linear/log trapezoidal method.
Measured: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7
Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.
Measured: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7
AUC24 of PF-06669571 refers to the area under the curve from time zero to 24 hours post dose on Day 7. AUC24 was determined by using linear/log trapezoidal method
Measured: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start16 Nov 2015
- Primary completion13 May 2016
- Study completion13 May 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 Idiopathic Parkinson's DiseaseStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565628
- Sponsor's protocol ID
- B7821002
- Status last verified
- Apr 2017
- First submitted
- 28 Sep 2015
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.
PubMed 29478239
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT02565628
- Acronym / sponsor ID
- B7821002
- Conditions
- Idiopathic Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 13 May 2016 (actual)
- Study completion
- 13 May 2016 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-06669571 | Experimental | Drug: PF-06669571Once daily (QD) for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboQD for 7 days |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
- Must be Hoehn \& Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
- Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.
Key exclusion criteria (1 listed)
- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
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-066695711 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days | Drug | PF-06669571 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7.
Time frame: Day 7
The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson's disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson's disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson's disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson's disease. Higher total scores indicate more severe motor signs of Parkinson's disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit
Time frame: Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)
The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act or some intent to act, with specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.
Time frame: Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)
Number of participants with new onset and worsening of post-baseline suicidality was reported
Number of Participants With Treatment Emergent Adverse Events (All Causalities)
Time frame: Day 1 to 28 calendar days after the last dose of investigational product
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Time frame: Screening, Days -1, 1, 7 and 8, and follow-up visit
Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP <90 millimeters of mercury (mmHg); (2) absolute standing SBP <90 mmHg; (3)absolute supine DBP<50mmHg; (4)absolute standing DBP<50mmHg (5) absolute supine pulse rate <40 beats per minute (bpm); (6) absolute supine pulse rate >120 bpm;(7) absolute standing pulse rate <40 bpm; (8) absolute standing pulse rate >140 bpm.
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
Time frame: Screening, Days -1, 1, 7 and 8, and follow-up visit
The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) >=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP >=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) >=20 mmHg
Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
Time frame: Screening, Days -1, 1, 7 and 8, and follow-up visit
The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) >=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) >=20 mmHg
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
Time frame: Screening, Days 1, 7, and 8, and follow-up visit
The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec
Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
Time frame: Screening, Days 1, 7, and 8, and follow-up visit
Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.
Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)
Time frame: Screening, Days 1, 4, and 7, and follow-up visit
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7
Time frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7
Time frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7
Time frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7
Time frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29478239Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
9 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-06669571 in people with Idiopathic Parkinson's Disease, run by Pfizer at 9 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 1 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 7 Aug 2017). 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?
Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7. (time frame: Day 7). The study lists 10 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 NCT02565628, 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 24 Jul 2023.