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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02936492
• Other study ID #: 17014
• Status: Terminated
• Phase: Phase 1
• First received: October 17, 2016
• Last updated: November 6, 2017
• Start date: October 24, 2016
• Est. completion date: October 16, 2017

Study information

• Verified date: November 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic safety following single and multiple dermal administration of BAY1003803

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: October 16, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BAY1003803 0.01% lipophilic cream
Topical administration for 22 h per day
• BAY1003803 0.1% lipophilic cream
Topical administration for 22 h per day
• BAY1003803 0.01% ointment
Topical administration for 22 h per day
• BAY1003803 0.1% ointment
Topical administration for 22 h per day
• Lipophilic cream vehicle
Topical administration for 22 h per day
• Ointment vehicle
Topical administration for 22 h per day
• Clobetasol propionate
Topical administration for 22 h per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol serum levels for safety		Up to 2 weeks
Primary	Frequency of treatment-emergent adverse events (TEAEs)		Up to 2 weeks
Primary	Nature of treatment-emergent adverse events (TEAEs)		Up to 2 weeks
Secondary	Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)		Day 1 to 3 at 8:00 am
Secondary	Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)		Day 1 to 8 at 8:00 am
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)

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