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A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Rheumatoid Arthritis (RA) or Psoriasis
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)
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 65 Years|
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.
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Bayer Study Director|
|Principal Investigator Affiliation||Bayer|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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