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A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Rheumatoid Arthritis (RA) or Psoriasis

Study Purpose

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with RA or psoriasis (Part 2) To assess the pharmacokinetic (PK) properties of total BAY 1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with RA or psoriasis (Part 2)

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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 RA or psoriasis) - Male patients, 18 to 65 years of age (inclusive) or female, postmenopausal patients, 45 to 65 years of age (inclusive).
  • - Body mass index above or equal to 18.5 and lower or equal to 32 kg/m2 and a body weight above or equal 50 kg Rheumatoid arthritis - A documented diagnosis of RA, obtained at least 6 months prior to study drug administration, fulfilling the American College of Rheumatology/ European League Against Rheumatism (2010 ACR/EULAR) classification criteria.
- Concomitant treatment with methotrexate for at least 12 weeks, with a stable dose for at least 4 weeks prior to randomization Psoriasis - A documented diagnosis of psoriasis, obtained at least 6 months prior to study drug administration with mild to moderate plaque psoriasis, defined by involved body surface area (BSA) above or equal 3%, Psoriasis Area and Severity Index (PASI) score of above or equal 5, and 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03493269

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Bayer

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Bayer Study Director
Principal Investigator Affiliation Bayer

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Germany

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Healthy Volunteers
Study Website: View Trial Website

Contact a Trial Team

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International Sites

Charité Research Organisation GmbH, Berlin, Germany

Status

Recruiting

Address

Charité Research Organisation GmbH

Berlin, , 10117

Site Contact

(+) 1-888-8422937

Nearest Location

Site Contact

(+) 1-888-8422937

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