Psoriasis
Conditions
Keywords
Phase I, Healthy volunteers
Brief summary
Systemic safety following single and multiple dermal administration of BAY1003803
Interventions
DRUGBAY1003803 0.01% lipophilic cream
Topical administration for 22 h per day
DRUGBAY1003803 0.1% lipophilic cream
Topical administration for 22 h per day
DRUGBAY1003803 0.01% ointment
Topical administration for 22 h per day
DRUGBAY1003803 0.1% ointment
Topical administration for 22 h per day
DRUGLipophilic cream vehicle
Topical administration for 22 h per day
DRUGOintment vehicle
Topical administration for 22 h per day
Topical administration for 22 h per day
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subject * Age: 18 to 64 years (inclusive) at the first screening visit * Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit * Non-smoker at least 3 months prior to study start and during the study * Healthy skin on which reddening can be easily recognized
Exclusion criteria
* A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases) * Infections and febrile illness within 4 week before the first study drug administration * Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them * Inoculations with live vaccine within 8 weeks before the first study drug administration * Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators * Human leukocyte antigen-DR (HLA-DR) \< 15000 AB/monocyte
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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) |
| 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 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 |
| 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 |
Countries
Germany
Outcome results
None listed