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

Completed

• Conditions: 10023213; Rheumatoid arthritis

• Registration Number: NL-OMON44381
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-04-02
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to investigate safety and tolerability of BAY<br /><br>1834845 with and without methotrexate.</p><br>