BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study

Phase 1

Terminated

• Conditions: Psoriasis
• Interventions: Drug: BAY1003803 0.01% lipophilic cream; Drug: Lipophilic cream vehicle; Drug: Clobetasol propionate; Drug: BAY1003803 0.1% lipophilic cream; Drug: Ointment vehicle; Drug: BAY1003803 0.01% ointment; Drug: BAY1003803 0.1% ointment

• Registration Number: NCT02936492
• Lead Sponsor: Bayer

Brief Summary

Systemic safety following single and multiple dermal administration of BAY1003803

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Study Start: 2016-10-24
• Primary Completion: 2017-04-18
• Study Completion: 2017-10-16
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY1003803	BAY1003803 0.01% lipophilic cream	Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
BAY1003803	BAY1003803 0.1% lipophilic cream	Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
BAY1003803	BAY1003803 0.01% ointment	Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
BAY1003803	BAY1003803 0.1% ointment	Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
Placebo	Lipophilic cream vehicle	Topical treatment using matching amount of placebo
Placebo	Ointment vehicle	Topical treatment using matching amount of placebo
Clobetasol propionate	Clobetasol propionate	Topical treatment using 16.5 mg of clobetasol propionate per subject

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)