Trial Condition(s):

Inflammation

Food effect, oral & intravenous pharmacokinetics and absolute bioavailability of BAY1834845 including drug-drug interaction with methotrexate

Bayer Identifier:

18387

ClinicalTrials.gov Identifier:

NCT03244462

EudraCT Number:

2016-004393-18

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
10
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1834845
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

PRAHealthSciences

GRONINGEN, Netherlands, 9728 NZ

Status
Completed
 

Trial Design