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

NCT02936492 | Terminated Phase 1

• 1 other identifier: 17014
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic safety following single and multiple dermal administration of BAY1003803

Conditions

Psoriasis

Keywords

Phase I; Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (3)

BAY1003803

EXPERIMENTAL

Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject

Drug: BAY1003803 0.01% lipophilic cream; Drug: BAY1003803 0.1% lipophilic cream; Drug: BAY1003803 0.01% ointment; Drug: BAY1003803 0.1% ointment

Placebo

PLACEBO COMPARATOR

Topical treatment using matching amount of placebo

Drug: Lipophilic cream vehicle; Drug: Ointment vehicle

Clobetasol propionate

ACTIVE COMPARATOR

Topical treatment using 16.5 mg of clobetasol propionate per subject

Drug: Clobetasol propionate

Interventions

BAY1003803 0.01% lipophilic cream DRUG

Topical administration for 22 h per day

BAY1003803

BAY1003803 0.1% lipophilic cream DRUG

Topical administration for 22 h per day

BAY1003803

BAY1003803 0.01% ointment DRUG

Topical administration for 22 h per day

BAY1003803

BAY1003803 0.1% ointment DRUG

Topical administration for 22 h per day

BAY1003803

Lipophilic cream vehicle DRUG

Topical administration for 22 h per day

Placebo

Ointment vehicle DRUG

Topical administration for 22 h per day

Placebo

Clobetasol propionate DRUG

Topical administration for 22 h per day

Clobetasol propionate

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Hamburg, 20251, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Ointments; Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 18, 2016
• Study Start: October 24, 2016
• Primary Completion: April 18, 2017
• Study Completion: October 16, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

DE (1)