Inflammation
Conditions
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 investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.
Interventions
DRUGBAY1834845
Single oral dose (IR \[immediate release\] tablets)
DRUGMethotrexate
Single dose of commercially available MTX
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of methotrexate in plasma in presence/absence of BAY1834845 | Multiple timepoints up to day 2 | in study part B |
| Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration | Multiple timepoints up to day 7 | in study part A |
| Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration | Multiple timepoints up to day 7 | in study part A |
| Absolute oral bioavailability (F) of BAY1834845 in the fasted state | Multiple timepoints up to day 7 | in study part A |
| AUC of methotrexate in plasma in presence/absence of BAY1834845 | Multiple timepoints up to day 2 | in study part B |
| 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 state | Multiple timepoints up to day 7 | in study part A |
| Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state | Multiple timepoints up to day 7 | in study part A |
Secondary
| Measure | Time frame |
|---|---|
| Severity of TEAEs in part A | Up to 9 weeks |
| Frequency of TEAEs in part B | Up to 6 weeks |
| Severity of TEAEs in part B | Up to 6 weeks |
| Frequency of Treatment Emergent Adverse Events (TEAEs) in part A | Up to 9 weeks |
Countries
Netherlands
Outcome results
None listed