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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000799-26 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of PF-06852231 after first-time administration to healthy adult subjects. The safety, tolerability, and pharmacokinetics of an active metabolite (PF-06892787) will also be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| PF-06852231 | Experimental | Single ascending doses of PF-06852231 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Treatment with placebo |
| |
| PF-06852231 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Treatment-related AE are any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Y days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed either yes or no by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category. | Baseline up to 14 days after last dose of study medication |
| Number of Participants With Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]). | Baseline up to 14 days after last dose of study medication |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and body temperature. | 0, 1, 2, 4, 8, 12, 24, 48, 72 hours(h) post-dose |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Absolute values and changes from baseline for ECG parameters | 0, 1, 2, 4, 8, 12, 24, 48, 72 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-06852231 | Maximum Observed Plasma Concentration (Cmax) for PF-06852231 | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06852231 |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
Screening supine BP greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
Other acute or chronic medical or psychiatric conditions
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| Drug |
Treatment with PF-06852231 |
|
| Abnormal rhythms as observed continuous cardiac telemetry |
Cardiac rhythms measured by continuous cardiac monitoring |
| 8 h post-dose |
Time to Reach Maximum Observed PF-06852231 Plasma Concentration (Tmax) |
| 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Area Under the Curve From Time Zero to Time of Last Measurable Plasma Concentration (AUClast) for PF-06852231 | AUClast = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to time of last measurable plasma concentration. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06852231 | AUCinf = 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). | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Plasma Decay Half-Life (t1/2) of PF-06852231 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06892787 (metabolite of PF-06852231) | Maximum Observed Plasma Concentration (Cmax) for PF-06892787 | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06892787 (metabolite of PF-06852231) | Time to Reach Maximum Observed PF-06892787 Plasma Concentration (Tmax) | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Area Under the Curve From Time Zero to Time of Last Measurable Plasma Concentration (AUClast) for PF-06892787 (metabolite of PF-06852231) | AUClast = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to time of last measurable plasma concentration. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06892787 (metabolite of PF-06852231) | AUCinf = 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). | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |
| Plasma Decay Half-Life (t1/2) of PF-06892787 (metabolite of PF-06852231) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose |