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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244462
• Other study ID #: 18387
• Secondary ID: 2016-004393-18
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 20, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• BAY1834845
Single oral dose (IR [immediate release] tablets)
• BAY1834845
I.v. infusion of [13C6]-labeled BAY1834845
• Methotrexate
Single dose of commercially available MTX

Locations

Country	Name	City	State
Netherlands	PRAHealthSciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Multiple timepoints up to day 7
Primary	Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state	in study part A	Multiple timepoints up to day 7
Primary	Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration	in study part A	Multiple timepoints up to day 7
Primary	Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration	in study part A	Multiple timepoints up to day 7
Primary	Absolute oral bioavailability (F) of BAY1834845 in the fasted state	in study part A	Multiple timepoints up to day 7
Primary	AUC of methotrexate in plasma in presence/absence of BAY1834845	in study part B	Multiple timepoints up to day 2
Primary	Cmax of methotrexate in plasma in presence/absence of BAY1834845	in study part B	Multiple timepoints up to day 2
Secondary	Frequency of Treatment Emergent Adverse Events (TEAEs) in part A		Up to 9 weeks
Secondary	Severity of TEAEs in part A		Up to 9 weeks
Secondary	Frequency of TEAEs in part B		Up to 6 weeks
Secondary	Severity of TEAEs in part B		Up to 6 weeks

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