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| ID | Type | Description | Link |
|---|---|---|---|
| C3291010 | Other Identifier | Alias Study Number |
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The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: AN2728 Ointment | Active Comparator |
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| Cohort 1: AN2728 Vehicle | Placebo Comparator |
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| Cohort 3: AN2728 Ointment | Active Comparator |
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| Cohort 3: AN2728 Vehicle | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2728 Ointment | Drug | 5mg/cm2, BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 12-lead ECG, clinical laboratory tests, urinalysis, spontaneous/elicited adverse event (AE) reporting, local site reactions, physical exam and vital signs (blood pressure, heart rate). | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile | Non-compartmental analysis of classic PK parameters: AUC(0-t), Cmax, Tmax, terminal t-1/2 (computed if data from majority of subjects permit) of AN2728, on Days 1 and 7 (or last day of administration). Trough plasma concentrations at the end of the dosing interval (Ctrough) collected at pre-morning dose. | 16 Days Maximum |
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Inclusion Criteria:
For psoriasis patients (in addition to the above criteria):
Exclusion Criteria:
For psoriasis patients (in addition to the above exclusion criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Sepehr Shakib, MB BS, PhD | Royal Adelaide Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX (A Division of IDT Australia Ltd) | Adelaide | 5000 | Australia |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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| AN2728 Vehicle |
| Drug |
5mg/cm2 BID |
|