Trial Outcomes & Findings for PF-06669571 In Subjects With Idiopathic Parkinson's Disease (NCT NCT02565628)
NCT ID: NCT02565628
Last Updated: 2023-07-24
Results Overview
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.
COMPLETED
PHASE1
20 participants
Day 7
2023-07-24
Participant Flow
A total of 20 participants were randomized, 19 participants were treated. One participant was randomized but withdrew consent before receiving any treatment. This subject was not included in any analysis set.
Participant milestones
| Measure |
PF-06669571 0.5 mg
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
Received Treatment
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Baseline characteristics by cohort
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
67.9 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
66.6 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: All enrolled participants who started treatment.
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.
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
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 Percentage
Standard Error 7.21
|
-14.21 Percentage
Standard Error 7.60
|
PRIMARY outcome
Timeframe: Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)Population: All enrolled participants who started treatment.
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").
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
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
Day -2
|
0 participants
|
0 participants
|
|
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
Day 8
|
0 participants
|
0 participants
|
|
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
Follow-up visit
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)Population: All enrolled participants who started treatment
Number of participants with new onset and worsening of post-baseline suicidality was reported
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 to 28 calendar days after the last dose of investigational productPopulation: All enrolled participants who started treatment
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.
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (All Causalities)
|
6 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Screening, Days -1, 1, 7 and 8, and follow-up visitPopulation: All enrolled participants who started treatment
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.
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Supine Pulse Rate >120 BPM
|
0 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Standing Pulse Rate <40 BPM
|
0 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Supine Systolic BP <90 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Standing Systolic BP <90 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Supine Diastolic BP <50 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Standing Diastolic BP <50 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Supine Pulse Rate <40 BPM
|
0 participants
|
0 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
Standing Pulse Rate >140 BPM
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening, Days -1, 1, 7 and 8, and follow-up visitPopulation: All enrolled participants who started treatment
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
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
Criterion A
|
1 participants
|
1 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
Criterion B
|
0 participants
|
1 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
Criterion C
|
0 participants
|
1 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
Criterion D
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Screening, Days -1, 1, 7 and 8, and follow-up visitPopulation: All enrolled participants who started treatment
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
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
Criterion A
|
5 participants
|
3 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
Criterion B
|
4 participants
|
2 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
Criterion C
|
3 participants
|
3 participants
|
|
Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
Criterion D
|
3 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Screening, Days 1, 7, and 8, and follow-up visitPopulation: All enrolled participants who started treatment
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
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
Criterion E
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
Criterion A
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
Criterion B
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
Criterion C
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
Criterion D
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening, Days 1, 7, and 8, and follow-up visitPopulation: All enrolled participants who started treatment
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.
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
Criterion C
|
2 participants
|
0 participants
|
|
Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
Criterion A
|
0 participants
|
0 participants
|
|
Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
Criterion B
|
0 participants
|
0 participants
|
|
Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
Criterion D
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening, Days 1, 4, and 7, and follow-up visitPopulation: All enrolled participants who started treatment.
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).
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 Participants
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7Population: The PF-06669571 pharmacokinetics(PK) concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.
Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7
Day 1
|
16.87 ng/mL
Geometric Coefficient of Variation 30
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7
Day 7
|
92.51 ng/mL
Geometric Coefficient of Variation 31
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7Population: The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.
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.
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7
Day 1
|
150.8 ng*hr/mL
Geometric Coefficient of Variation 28
|
—
|
|
Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7
Day 7
|
917.5 ng*hr/mL
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7Population: The PF-06669571 PK concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.
Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7
Day 1
|
3.35 hr
Interval 1.4 to 8.42
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7
Day 7
|
3.19 hr
Interval 1.42 to 5.42
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7Population: The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.
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
Outcome measures
| Measure |
PF-06669571 0.5 mg
n=10 Participants
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7
|
1626 ng*hr/mL
Geometric Coefficient of Variation 38
|
—
|
Adverse Events
PF-06669571 0.5 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06669571 0.5 mg
n=10 participants at risk
PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
Placebo
n=9 participants at risk
Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10
|
11.1%
1/9
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10
|
22.2%
2/9
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10
|
22.2%
2/9
|
|
General disorders
Ill-defined disorder
|
20.0%
2/10
|
0.00%
0/9
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
|
0.00%
0/9
|
|
Nervous system disorders
Dystonia
|
10.0%
1/10
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
0.00%
0/9
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10
|
0.00%
0/9
|
|
Nervous system disorders
Resting tremor
|
0.00%
0/10
|
11.1%
1/9
|
|
Psychiatric disorders
Abnormal dreams
|
10.0%
1/10
|
0.00%
0/9
|
|
Renal and urinary disorders
Nocturia
|
10.0%
1/10
|
0.00%
0/9
|
|
Vascular disorders
Hypotension
|
10.0%
1/10
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER