A Phase 1 interventional study of PF-06669571 and Placebo in Idiopathic Parkinson's Disease, sponsored by Pfizer. Completed at 9 sites in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Once daily (QD) for 7 days
Drug: PF-06669571
QD for 7 days
Drug: Placebo
1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
Placebo
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.
Time frame: 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").
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Screening, Days 1, 4, and 7, and follow-up visit
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
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
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.
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
Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.
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
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
Time frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7
| Milestone | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Started | 10 | 9 |
| Received treatment | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
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.
| Percentage | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| 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. | -19.24 ± 7.21 | -14.21 ± 7.60 |
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").
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Day -2 | 0 | 0 |
| Day 8 | 0 | 0 |
| Follow-up visit | 0 | 0 |
Number of participants with new onset and worsening of post-baseline suicidality was reported
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Number of Participants With New Onset and Worsening of Post-Baseline Suicidality. | 0 | 0 |
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.
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (All Causalities) | 6 | 5 |
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.
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Supine Systolic BP <90 mmHg | 0 | 0 |
| Standing Systolic BP <90 mmHg | 1 | 0 |
| Supine Diastolic BP <50 mmHg | 0 | 0 |
| Standing Diastolic BP <50 mmHg | 0 | 0 |
| Supine Pulse Rate <40 BPM | 0 | 0 |
| Supine Pulse Rate >120 BPM | 0 | 0 |
| Standing Pulse Rate <40 BPM | 0 | 0 |
| Standing Pulse Rate >140 BPM | 0 | 0 |
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
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Criterion A | 1 | 1 |
| Criterion B | 0 | 1 |
| Criterion C | 0 | 1 |
| Criterion D | 1 | 1 |
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
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Criterion A | 5 | 3 |
| Criterion B | 4 | 2 |
| Criterion C | 3 | 3 |
| Criterion D | 3 | 2 |
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
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Criterion A | 0 | 0 |
| Criterion B | 0 | 0 |
| Criterion C | 0 | 0 |
| Criterion D | 0 | 0 |
| Criterion E | 0 | 0 |
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.
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Criterion A | 0 | 0 |
| Criterion B | 0 | 0 |
| Criterion C | 2 | 0 |
| Criterion D | 0 | 0 |
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).
| participants | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality) | 8 | 5 |
Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7
| ng/mL | PF-06669571 0.5 mg |
|---|---|
| Day 1 | 16.87 ± 30 |
| Day 7 | 92.51 ± 31 |
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.
| ng*hr/mL | PF-06669571 0.5 mg |
|---|---|
| Day 1 | 150.8 ± 28 |
| Day 7 | 917.5 ± 35 |
Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.
| hr | PF-06669571 0.5 mg |
|---|---|
| Day 1 | 3.35 (1.40 to 8.42) |
| Day 7 | 3.19 (1.42 to 5.42) |
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
| ng*hr/mL | PF-06669571 0.5 mg |
|---|---|
| Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7 | 1626 ± 38 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-06669571 0.5 mg | — | 0/10 (0%) | 6/10 (60%) |
| Placebo | — | 0/9 (0%) | 5/9 (55.6%) |
| Event | PF-06669571 0.5 mg | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 2/10 | 2/9 |
| VomitingGastrointestinal disorders | 1/10 | 2/9 |
| Dry mouthGastrointestinal disorders | 2/10 | 1/9 |
| Ill-defined disorderGeneral disorders | 2/10 | 0/9 |
| ContusionInjury, poisoning and procedural complications | 0/10 | 1/9 |
| FallInjury, poisoning and procedural complications | 0/10 | 1/9 |
| Resting tremorNervous system disorders | 0/10 | 1/9 |
| Upper respiratory tract infectionInfections and infestations | 1/10 | 0/9 |
| DizzinessNervous system disorders | 1/10 | 0/9 |
| DystoniaNervous system disorders | 1/10 | 0/9 |
| Age, Continuous(years) | PF-06669571 0.5 mg | Placebo | Total |
|---|---|---|---|
| Mean | 65.5 ± 7.4 | 67.9 ± 5.9 | 66.6 ± 6.6 |
| Sex: Female, Male(Participants) | PF-06669571 0.5 mg | Placebo | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 6 | 4 | 10 |
Ran from Nov 2015 to primary completion in May 2016, 5 months.
Results were first posted in Aug 2017, 1 year 2 months after primary completion.
Of 124 industry-sponsored phase 1 interventional studies under Parkinson Disease, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's 5 months is below that.
Counting every sponsor, half of 201 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: PF-06669571