NCT03244462

Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	BAY1834845	Single oral dose (IR \[immediate release\] tablets)
DRUG	BAY1834845	I.v. infusion of \[13C6\]-labeled BAY1834845
DRUG	Methotrexate	Single dose of commercially available MTX

Timeline

• Start date: 2017-08-18
• Primary completion: 2018-01-22
• Completion: 2018-07-20
• First posted: 2017-08-09
• Last updated: 2019-07-15

Locations

1 site across 1 country: Netherlands