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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple repeat oral doses of PF-06372865 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects receiving placebo |
|
| PF-06372865 | Experimental | Subjects receiving PF-06372865 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| PF-06372865 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug. A serious adverse events (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category. | Baseline up to 28-35 days after last dose of study medication |
| Change From Baseline in Vital Signs | Measurement of systolic and diastolic blood pressure and pulse rate | 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17 |
| Change From Baseline in Electrocardiogram (ECG) Parameters | Measurement of the following ECG parameters: QT interval, QTcF, PR interval, RR interval, QRS interval, and heart rate. | 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17 |
| Number of Participants With Clinical Laboratory Abnormalities | Lab tests include: 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, folate); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy); other (follicle stimulating hormone, urine drug screening, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer 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 |
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| C000630159 | PF-06372865 |
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| Drug |
PF-06372865 |
|
| Baseline up to 7-10 days after last dose of study medication |
| Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 1 | Maximum observed plasma concentration | 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 1 | Time to reach maximum observed plasma concentration | 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 1 | Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 21 | Maximum observed plasma concentration | 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 21 | Time to reach maximum observed plasma concentration | 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 21 | Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose |
| Plasma Half-Life (t1/2) | Time for the plasma concentration to decrease by one half. | 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 21 |