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

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
BAY1834845
BAY1834845
Methotrexate
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammation

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts 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)

Sites / Locations

  • PRAHealthSciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Oral BAY1834845

Oral BAY1834845 + i.v. BAY1834845

Oral Methotrexate

Oral Methotrexate + oral BAY1834845

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
Severity of TEAEs in part A
Frequency of TEAEs in part B
Severity of TEAEs in part B

Full Information

First Posted
August 7, 2017
Last Updated
July 12, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03244462
Brief Title
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral BAY1834845
Arm Type
Experimental
Arm Description
Study Part A, cross over sequence: single oral dose of BAY1834845 single oral dose of BAY1834845 + i.v. BAY1834845 single oral dose of BAY1834845 under fed conditions
Arm Title
Oral BAY1834845 + i.v. BAY1834845
Arm Type
Experimental
Arm Description
Study Part A, cross over sequence: single oral dose of BAY1834845+ i.v. BAY1834845 single oral dose of BAY1834845 single oral dose of BAY1834845 under fed conditions
Arm Title
Oral Methotrexate
Arm Type
Experimental
Arm Description
Study part B, cross over sequence: single oral dose of methotrexate (MTX) single oral dose of MTX + single oral dose of BAY1834845
Arm Title
Oral Methotrexate + oral BAY1834845
Arm Type
Experimental
Arm Description
Study part B, cross over sequence: single oral dose of methotrexate (MTX) + single oral dose of BAY1834845 single oral dose of MTX
Intervention Type
Drug
Intervention Name(s)
BAY1834845
Intervention Description
Single oral dose (IR [immediate release] tablets)
Intervention Type
Drug
Intervention Name(s)
BAY1834845
Intervention Description
I.v. infusion of [13C6]-labeled BAY1834845
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Single dose of commercially available MTX
Primary Outcome Measure Information:
Title
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
Description
in study part A
Time Frame
Multiple timepoints up to day 7
Title
Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
Description
in study part A
Time Frame
Multiple timepoints up to day 7
Title
Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
Description
in study part A
Time Frame
Multiple timepoints up to day 7
Title
Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
Description
in study part A
Time Frame
Multiple timepoints up to day 7
Title
Absolute oral bioavailability (F) of BAY1834845 in the fasted state
Description
in study part A
Time Frame
Multiple timepoints up to day 7
Title
AUC of methotrexate in plasma in presence/absence of BAY1834845
Description
in study part B
Time Frame
Multiple timepoints up to day 2
Title
Cmax of methotrexate in plasma in presence/absence of BAY1834845
Description
in study part B
Time Frame
Multiple timepoints up to day 2
Secondary Outcome Measure Information:
Title
Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
Time Frame
Up to 9 weeks
Title
Severity of TEAEs in part A
Time Frame
Up to 9 weeks
Title
Frequency of TEAEs in part B
Time Frame
Up to 6 weeks
Title
Severity of TEAEs in part B
Time Frame
Up to 6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
PRAHealthSciences
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.

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

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