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

Bayer

Status and phase

Completed

Phase 1

Conditions

Inflammation

Treatments

Drug: Methotrexate

Drug: BAY1834845

Study type

Interventional

Funder types

Industry

Identifiers

NCT03244462

18387

2016-004393-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 4 patient groups

Oral BAY1834845

Experimental group

Description:

Study Part A, cross over sequence: 1. single oral dose of BAY1834845 2. single oral dose of BAY1834845 + i.v. BAY1834845 3. single oral dose of BAY1834845 under fed conditions

Treatment:

Drug: BAY1834845

Oral BAY1834845 + i.v. BAY1834845

Experimental group

Description:

Study Part A, cross over sequence: 1. single oral dose of BAY1834845+ i.v. BAY1834845 2. single oral dose of BAY1834845 3. single oral dose of BAY1834845 under fed conditions

Treatment:

Drug: BAY1834845

Oral Methotrexate

Experimental group

Description:

Study part B, cross over sequence: 1. single oral dose of methotrexate (MTX) 2. single oral dose of MTX + single oral dose of BAY1834845

Treatment:

Drug: Methotrexate

Drug: BAY1834845

Oral Methotrexate + oral BAY1834845

Experimental group

Description: