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A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03493269
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).

To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).


Condition or disease Intervention/treatment Phase
Healthy Volunteers Psoriasis Drug: BAY1834845 Other: Matching Placebo Drug: Midazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : April 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: BAY1834845

Part 1 in healthy male subjects:

Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)

Drug: BAY1834845
Orally administered.

Drug: Midazolam
Part 1: Orally administered 1mg as a single dose.

Placebo Comparator: Matching Placebo
Part 1: Matching placebo in healthy male subjects.
Other: Matching Placebo
Orally administered.

Drug: Midazolam
Part 1: Orally administered 1mg as a single dose.

Experimental: Chosen dose of BAY1834845
Part 2: This dose level will be adminstered in female and male patients with psoriasis
Drug: BAY1834845
Orally administered.

Placebo Comparator: Placebo
Part 2: The placebo will be adminstered in female and male patients with psoriasis
Other: Matching Placebo
Orally administered.




Primary Outcome Measures :
  1. Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: Approximately 47 days ]
    Part 1 in healthy male subject

  2. Severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Approximately 47 days ]
    Part 1 in healthy male subject

  3. Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: Approximately 84 days ]
    Part 2: Patients with psoriasis

  4. Severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Approximately 84 days ]
    Part 2: Patients with psoriasis

  5. AUC(0-24)md of BAY1834845 [ Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2 ]
    Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

  6. AUC(0-12)md of BAY1834845 [ Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1 ]
    Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing

  7. Cmax,md of BAY1834845 [ Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1 ]
    Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

  8. Cav,md of BAY1834845 [ Time Frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2 ]
    Part 1 Cav:Average concentration within a dosing interval after multiple dosing

  9. AUC(0-24)md of BAY1834845 [ Time Frame: Part 2: one day between day 35 and 42 ]
    Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

  10. AUC(0-12)md of BAY1834845 [ Time Frame: Part 2: one day between day 35 and 42 ]
    Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing

  11. Cmax,md of BAY1834845 [ Time Frame: Part 2: one day between day 35 and 42 ]
    Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

  12. Cav, md of BAY1834845 [ Time Frame: Part 2: one day between day 35 and 42 ]
    Part 2: Cav: Average concentration within a dosing interval after multiple dosing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Part 1 (healthy male subjects)

  • Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening
  • Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis)
  • Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)
  • Body mass index above or equal to 18.5 and lower or equal to 35 kg/m*2 and a body weight above 50 kg
  • A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.

Exclusion Criteria:

  • History of hypersensitivity to any of the components of the study drug
  • Any clinically relevant abnormal findings in safety laboratory parameters and ECG
  • History of tuberculosis (TB) or active or latent tuberculosis
  • Receipt of live or attenuated vaccine 90 days prior to the first dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493269


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Germany
Charité Research Organisation GmbH Recruiting
Berlin, Germany, 10117
PAREXEL GmbH Recruiting
Berlin, Germany, 14050
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03493269    
Other Study ID Numbers: 18385
2017-001817-10 ( EudraCT Number )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action