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This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose-1 | Experimental | Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design |
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| Single Ascending Dose-2 | Experimental | Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design |
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| Multiple Ascending Dose-1 | Experimental | Daily dose of PF-06669571 in healthy volunteers |
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| Multiple Ascending Dose-2 | Experimental | Daily dose of PF-06669571 in healthy volunteers |
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| Multiple Ascending Dose-3 | Experimental | Daily dose of PF-06669571 in healthy volunteers |
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| Multiple Ascending Dose-4 | Experimental | Daily dose of PF-06669571 in healthy volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06669571 | Drug | Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | 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, without specific plan or 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"). | screening,Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) after single dose | Cmax after a single dose | 0-Day 5 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose |
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Inclusion Criteria:
Female subjects of non-childbearing potential must meet at least one of the following criteria:
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Multiple Ascending Dose-5 | Experimental | Daily dose of PF-06669571 in healthy volunteers |
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| PF-06669571 | Drug | Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo |
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| PF-06669571 | Drug | Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days |
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| PF-06669571 | Drug | Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days |
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| PF-06669571 | Drug | Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme |
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| PF-06669571 | Drug | Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme |
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| PF-06669571 | Drug | Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme |
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
| 0-Day 5 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose | 0-Day 5 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose | Tmax after single dose | 0-Day 5 |
| Plasma Decay Half-Life (t1/2) after single dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose | 0-Day 5 |
| Apparent Oral Clearance (CL/F) after single dose | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose | 0-Day 5 |
| Apparent Volume of Distribution (Vz/F) after single dose | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0-Day 5 |
| Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose | 0-Day 18 |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses | 0-Day 18 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses | 0-Day 18 |
| Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0-Day 18 |
| Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses | 0-Day 18 |
| Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses | 0-Day 18 |
| Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses | 0-day 18 |
| Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses | 0-Day 18 |
| Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0-Day 18 |
| Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0-Day 18 |
| Renal clearance (CLr) on day 14 | 0-Day 18 |
| Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses | 0-Day 18 |
| Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses | 0-Day 18 |
| Peak to Trough ratio at Steady State (PTR) | Cmax to Cmin ratio at steady state | 0-Day 18 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C000628211 | PF-06669571 |
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