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Systemic safety following single and multiple dermal administration of BAY1003803
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1003803 | Experimental | Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject |
|
| Placebo | Placebo Comparator | Topical treatment using matching amount of placebo |
|
| Clobetasol propionate | Active Comparator | Topical treatment using 16.5 mg of clobetasol propionate per subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1003803 0.01% lipophilic cream | Drug | Topical administration for 22 h per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol serum levels for safety | Up to 2 weeks | |
| Frequency of treatment-emergent adverse events (TEAEs) | Up to 2 weeks | |
| Nature of treatment-emergent adverse events (TEAEs) | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose) | Day 1 to 3 at 8:00 am | |
| Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose) | Day 1 to 8 at 8:00 am |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamburg | 20251 | Germany |
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| BAY1003803 0.1% lipophilic cream |
| Drug |
Topical administration for 22 h per day |
|
| BAY1003803 0.01% ointment | Drug | Topical administration for 22 h per day |
|
| BAY1003803 0.1% ointment | Drug | Topical administration for 22 h per day |
|
| Lipophilic cream vehicle | Drug | Topical administration for 22 h per day |
|
| Ointment vehicle | Drug | Topical administration for 22 h per day |
|
| Clobetasol propionate | Drug | Topical administration for 22 h per day |
|
| Maximum plasma concentration (Cmax) after single dose of BAY1003803 | At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours |
| Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803 | At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours |
| Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803 | At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours |
| Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803 | At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6) |
| Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803 | At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6) |
| 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 |
|---|---|
| D009824 | Ointments |
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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