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

Bayer10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Inflammation

Interventions

BAY1834845DRUG

Single oral dose (IR \[immediate release\] tablets)

BAY1834845DRUG

I.v. infusion of \[13C6\]-labeled BAY1834845

MethotrexateDRUG

Single dose of commercially available MTX

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

PRAHealthSciences

Groningen, Netherlands

Outcomes

Primary Outcomes

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

in study part A