stop_circleTerminated/Withdrawn

Psoriasis

Bayer Identifier:

17014

ClinicalTrials.gov Identifier:

NCT02936492

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY1003803 Single and multiple dose escalation, safety, tolerability and pharmacokinetics study

Trial purpose

Systemic safety following single and multiple dermal administration of BAY1003803

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - 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


  • - 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

Trial summary

Enrollment Goal
32
Trial Dates
October 2016 - October 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1003803
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Hamburg, 20251, Germany

Primary Outcome

  • Cortisol serum levels for safety
    date_rangeTime Frame:
    Up to 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Frequency of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Nature of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)
    date_rangeTime Frame:
    Day 1 to 3 at 8:00 am
    enhanced_encryption
    Safety Issue:
    Yes
  • Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)
    date_rangeTime Frame:
    Day 1 to 8 at 8:00 am
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum plasma concentration (Cmax) after single dose of BAY1003803
    date_rangeTime Frame:
    At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803
    date_rangeTime Frame:
    At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours
    enhanced_encryption
    Safety Issue:
    No
  • Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803
    date_rangeTime Frame:
    At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
    enhanced_encryption
    Safety Issue:
    No
  • Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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