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This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral doses as an immediate-release or modified-release formulation to healthy adult participants. Part B of this study will evaluate the relative bioavailability of a modified-release formulation of PF-06842874 for its potential use in future clinical studies. The effect of food on PF-06842874 pharmacokinetics may also be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06842874/Placebo | Experimental | Single dose administration of PF-06842874 or placebo |
|
| Relative Bioavailability | Experimental | Determination of relative bioavailability of modified-release formulation relative to immediate-release formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06842874 | Drug | Single dose administration of PF-06842874 |
| |
| 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. | Baseline up to 35 days after last dose of study medication |
| Number of Participants With Clinical Laboratory Abnormalities | The following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).](streamdown:incomplete-link) | Baseline up to 10 days after last dose of study medication |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | The following parameters will be analyzed for examination of vital signs: systolic blood pressure, diastolic blood pressure, and pulse rate. | 0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Measurements of heart rate, PR interval, QT interval, QTc intervals, and QRS complex | 0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose |
| Abnormal rhythms as observed continuous cardiac monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-06842874 | Maximum observed plasma concentration for immediate-release and modified-release formulations of PF-06842874 | 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06842874 |
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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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States | ||
| Pfizer New Haven Clinical Research Unit |
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| Label | URL |
|---|---|
| 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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participant- and investigator-blind, sponsor-open
| Placebo |
| Drug |
Single dose administration of placebo |
|
| Relative Bioavailability | Drug | Relative bioavailability assessment of modified-release formulation |
|
Cardiac rhythms measured by continuous cardiac telemetry |
| 0 to 8 hours post-dose |
| Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings | A complete physical examination includes, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A limited physical examination includes, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. | Baseline up to 10 days after last dose of study medication |
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for immediate-release and modified-release formulations of PF-06842874 |
| 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06842874 | Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0-inf) for immediate-release and modified-release formulations of PF-06842874. It is obtained from AUC(0-t) plus AUC (t-inf). | 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06842874 | Time to reach maximum observed plasma concentration for immediate-release and modified-release formulations of PF-06842874 | 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose |
| Plasma Half-Life (t1/2) of PF-06842874 | Plasma half-life is the time measured for the plasma concentration to decrease by one half for immediate-release and modified-release formulations of PF-06842874. | 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose |
| New Haven |
| Connecticut |
| 06511 |
| United States |