Trial Condition(s):
Inflammation
Food effect, oral & intravenous pharmacokinetics and absolute bioavailability of BAY1834845 including drug-drug interaction with methotrexate
Bayer Identifier:
18387
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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 investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.
Inclusion Criteria
- 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 Criteria
- 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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations PRAHealthSciences GRONINGEN, Netherlands, 9728 NZ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Open label, randomized, cross-over study to explore the pharmacokinetics of BAY1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
4
Primary Outcome
- AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted statein study part ATimeframe: Multiple timepoints up to day 7
- Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted statein study part ATimeframe: Multiple timepoints up to day 7
- Total body clearance (CL) of [13C6] BAY1834845 after intravenous administrationin study part ATimeframe: Multiple timepoints up to day 7
- Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administrationin study part ATimeframe: Multiple timepoints up to day 7
- Absolute oral bioavailability (F) of BAY1834845 in the fasted statein study part ATimeframe: Multiple timepoints up to day 7
- AUC of methotrexate in plasma in presence/absence of BAY1834845in study part BTimeframe: Multiple timepoints up to day 2
- Cmax of methotrexate in plasma in presence/absence of BAY1834845in study part BTimeframe: Multiple timepoints up to day 2
Secondary Outcome
- Frequency of Treatment Emergent Adverse Events (TEAEs) in part ATimeframe: Up to 9 weeks
- Severity of TEAEs in part ATimeframe: Up to 9 weeks
- Frequency of TEAEs in part BTimeframe: Up to 6 weeks
- Severity of TEAEs in part BTimeframe: Up to 6 weeks
Additional Information
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