Open label, randomized, cross-over study to explore the pharmacokinetics of BAY 1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY 1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects

Open label, randomized, cross-over study to explore the pharmacokinetics of BAY 1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY 1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects - BAY 1834845 FE, BA, Methotrexate DDI Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44381

Enrollment

Registered

2017-08-02

Start date

2017-08-18

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Part A: During the study you will receive BAY 1834845 as an oral tablet with 240 mL water. The study will consist of 3 periods during each of which the volunteer will receive one dose of BAY 18348

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects - 18 - 50 years, inclusive - BMI: 18.0 - 30.0 kg/m², inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 3 months before the start of this study. In case of donating more than 0.5 liters of blood in the 4 week prior the start of this study.

Design outcomes

Primary

Measure	Time frame
The main objectives of this study are: To investigate the pharmacokinetics of BAY 1834845 in the absence and presence of food to determine absolute bioavailability and pharmacokinetics of BAY 1834845 using a simultaneous oral and intravenous [13C6] labeled micro tracer dose for the effect of a single oral dose of BAY 1834845 On the pharmacokinetics of a single oral dose of methotrexate administered.	—

Measure

Time frame

The main objectives of this study are: To investigate the pharmacokinetics of BAY 1834845 in the absence and presence of food to determine absolute bioavailability and pharmacokinetics of BAY 1834845 using a simultaneous oral and intravenous [13C6] labeled micro tracer dose for the effect of a single oral dose of BAY 1834845 On the pharmacokinetics of a single oral dose of methotrexate administered.

—

Secondary

Measure	Time frame
The secondary objectives are to investigate safety and tolerability of BAY 1834845 with and without methotrexate.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)