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

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

Systemic safety following single and multiple dermal administration of BAY1003803

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BAY1003803 0.01% lipophilic cream; Drug: BAY1003803 0.1% lipophilic cream; Drug: BAY1003803 0.01% ointment; Drug: BAY1003803 0.1% ointment; Drug: Lipophilic cream vehicle; Drug: Ointment vehicle; Drug: Clobetasol propionate

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20251

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAY1003803; Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject	Drug: BAY1003803 0.01% lipophilic cream; Topical administration for 22 h per day; Drug: BAY1003803 0.1% lipophilic cream; Topical administration for 22 h per day; Drug: BAY1003803 0.01% ointment; Topical administration for 22 h per day; Drug: BAY1003803 0.1% ointment; Topical administration for 22 h per day
Placebo Comparator: Placebo; Topical treatment using matching amount of placebo	Drug: Lipophilic cream vehicle; Topical administration for 22 h per day; Drug: Ointment vehicle; Topical administration for 22 h per day
Active Comparator: Clobetasol propionate; Topical treatment using 16.5 mg of clobetasol propionate per subject	Drug: Clobetasol propionate; Topical administration for 22 h per day

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2016
• Primary Completion (Actual): April 18, 2017
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Healthy volunteers; Phase I
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: 17014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No