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

Phase 1

Completed

• Conditions: Inflammation
• Interventions: Drug: BAY1834845; Drug: Methotrexate

• Registration Number: NCT03244462
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-09
• Study Start: 2017-08-18
• Primary Completion: 2018-01-22
• Study Completion: 2018-07-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral BAY1834845	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
Oral BAY1834845 + i.v. BAY1834845	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
Oral Methotrexate	BAY1834845	Study part B, cross over sequence: 1. single oral dose of methotrexate (MTX) 2. single oral dose of MTX + single oral dose of BAY1834845
Oral Methotrexate + oral BAY1834845	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
Oral Methotrexate	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
Oral Methotrexate + oral BAY1834845	Methotrexate	Study part B, cross over sequence: 1. single oral dose of methotrexate (MTX) + single oral dose of BAY1834845 2. single oral dose of MTX

Primary Outcome Measures

Name	Time	Method
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	Multiple timepoints up to day 7	in study part A
Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state	Multiple timepoints up to day 7	in study part A
Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration	Multiple timepoints up to day 7	in study part A
Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration	Multiple timepoints up to day 7	in study part A
Absolute oral bioavailability (F) of BAY1834845 in the fasted state	Multiple timepoints up to day 7	in study part A
AUC of methotrexate in plasma in presence/absence of BAY1834845	Multiple timepoints up to day 2	in study part B
Cmax of methotrexate in plasma in presence/absence of BAY1834845	Multiple timepoints up to day 2	in study part B

Secondary Outcome Measures

Name	Time	Method
Severity of TEAEs in part B	Up to 6 weeks
Frequency of Treatment Emergent Adverse Events (TEAEs) in part A	Up to 9 weeks
Severity of TEAEs in part A	Up to 9 weeks
Frequency of TEAEs in part B	Up to 6 weeks

Trial Locations

Locations (1)

PRAHealthSciences; 🇳🇱 Groningen, Netherlands