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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004231-68 |
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PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Experimental Arm | Experimental |
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| Cohort 2 Experimental Arm | Experimental |
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| Cohort 3 Experimental Arm | Experimental |
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| Cohort 3 Placebo Arm | Placebo Comparator |
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| Cohort 4 Experimental Arm | Experimental |
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| Cohort 4 Placebo Arm | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06263726 | Drug | Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back. |
| Measure | Description | Time Frame |
|---|---|---|
| Draize toxicity assessment score. | Changes from baseline on Draize toxicity assessment score. | Day 8, Day 28 |
| Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations. | Day 23, Day 28 | |
| Changes from baseline in 12 lead electrocardiogram (ECG) parameters. | Quantitative changes in ECG intervals. | Day 23, Day 28 |
| Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events. | Day 23, Day 28 | |
| Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis. | Day 23, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax) | Day 1, Day 14 | |
| Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day 1, Day 14 | |
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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 Investigational Site | 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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| PF-06263726 | Drug | Subjects will receive dose strength of 4% PF-06263276 (2.28 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back. |
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| PF-06263726 | Drug | Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. |
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| Placebo | Drug | Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. |
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| PF-06263726 | Drug | Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. |
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| Placebo | Drug | Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. |
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| Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)] |
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) |
| Day 1, Day 14 |
| Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | Day 1, Day 14 |
| Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)] | Day 1, Day 14 |
| Cohorts 3 and 4: Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Day 14 |
| Cohorts 3 and 4: Apparent Volume of Distribution (Vz/F) | 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. | Day 14 |
| Cohorts 3 and 4: Apparent Oral Clearance (CL/F) | 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. | Day 14 |