Clinical trial NCT02936492: BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study
Official title: Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled Design and Including a Positive Control Group
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Phase I
Healthy volunteers
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Systemic safety following single and multiple dermal administration of BAY1003803


Eligibility criteria: 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

Primary outcomes:
measure: Cortisol serum levels for safety
timeFrame: Up to 2 weeks
measure: Frequency of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 2 weeks
measure: Nature of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)
timeFrame: Day 1 to 3 at 8:00 am
measure: Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)
timeFrame: Day 1 to 8 at 8:00 am
measure: Maximum plasma concentration (Cmax) after single dose of BAY1003803
timeFrame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours
measure: Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803
timeFrame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours
measure: Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803
timeFrame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
measure: Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803
timeFrame: 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)
measure: Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803
timeFrame: 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)
Other outcomes:
Locations:
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: