Status:
COMPLETED
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate
Lead Sponsor:
Bayer
Conditions:
Inflammation
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investig...
Eligibility Criteria
Inclusion
- Male; healthy according to complete medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests as listed in the exclusion criteria given below.
- Age 18-50 years (inclusive) at the first screening visit.
- Body mass index: \>=18 kg/m² and \<=30 kg/m².
- Sexually active men must agree to practice adequate methods of contraception (protection).
- This applies for the time period between signing of the informed consent form and up to 90 days after the last administration of the study drug(s).
Exclusion
- Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal, liver, renal, lung or cardiovascular disorders, malignant tumors, known severe allergies, known or suspected immunodeficiency
- Medication history: drugs known to induce/inhibit liver enzymes
- Smoking
- Clinically relevant findings in
- physical
- ECG, blood pressure
- laboratory values
- Known hypersensitivity to study drug(s)
Key Trial Info
Start Date :
August 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03244462
Start Date
August 18 2017
End Date
July 20 2018
Last Update
July 15 2019
Active Locations (1)
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1
PRAHealthSciences
Groningen, Netherlands, 9728 NZ