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

Primary Purpose

Psoriasis

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BAY1003803 0.01% lipophilic cream

BAY1003803 0.1% lipophilic cream

BAY1003803 0.01% ointment

BAY1003803 0.1% ointment

Lipophilic cream vehicle

Ointment vehicle

Clobetasol propionate

About this trial

This is an interventional other trial for Psoriasis focused on measuring Phase I, Healthy volunteers

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

BAY1003803

Placebo

Clobetasol propionate

Arm Description

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

Topical treatment using matching amount of placebo

Topical treatment using 16.5 mg of clobetasol propionate per subject

Outcomes

Primary Outcome Measures

Cortisol serum levels for safety

Frequency of treatment-emergent adverse events (TEAEs)

Nature of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)

Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)

Maximum plasma concentration (Cmax) after single dose of BAY1003803

Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803

Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803

Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803

Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803

Full Information

NCT ID

NCT02936492

First Posted

October 17, 2016

Last Updated

November 6, 2017

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02936492

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Study Start Date

October 24, 2016 (Actual)

Primary Completion Date

April 18, 2017 (Actual)

Study Completion Date

October 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Systemic safety following single and multiple dermal administration of BAY1003803

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Phase I, Healthy volunteers

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY1003803

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Topical treatment using matching amount of placebo

Arm Title

Clobetasol propionate

Arm Type

Active Comparator

Arm Description

Topical treatment using 16.5 mg of clobetasol propionate per subject

Intervention Type

Drug

Intervention Name(s)

BAY1003803 0.01% lipophilic cream

Intervention Description