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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-18

Study Completion Date

2018-07-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Oral BAY1834845

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

Group Type EXPERIMENTAL

BAY1834845

Intervention Type DRUG

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

BAY1834845

Intervention Type DRUG

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

Oral BAY1834845 + i.v. BAY1834845

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

Group Type EXPERIMENTAL

BAY1834845

Intervention Type DRUG

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

BAY1834845

Intervention Type DRUG

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

Oral Methotrexate

Study part B, cross over sequence:

1. single oral dose of methotrexate (MTX)
2. single oral dose of MTX + single oral dose of BAY1834845

Group Type EXPERIMENTAL

BAY1834845

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Single dose of commercially available MTX

Oral Methotrexate + oral BAY1834845

Study part B, cross over sequence:

1. single oral dose of methotrexate (MTX) + single oral dose of BAY1834845
2. single oral dose of MTX

Group Type EXPERIMENTAL

BAY1834845

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

Single dose of commercially available MTX

Interventions

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BAY1834845

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

Intervention Type DRUG

BAY1834845

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

Intervention Type DRUG

Methotrexate

Single dose of commercially available MTX

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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).

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes