check_circleStudy Completed

Inflammation

Bayer Identifier:

18387

ClinicalTrials.gov Identifier:

NCT03244462

EudraCT Number:

2016-004393-18

EU CT Number:

Not Available
Food effect, oral & intravenous pharmacokinetics and absolute bioavailability of BAY1834845 including drug-drug interaction with methotrexate

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.

Key Participants Requirements

Sex

Male

Age

18 - 50 Years
  • - 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).
  • - 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
August 2017 - July 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1834845
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PRAHealthSciencesGRONINGEN, 9728 NZ, Netherlands

Primary Outcome

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

Secondary Outcome

  • Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
    date_rangeTime Frame:
    Up to 9 weeks
  • Severity of TEAEs in part A
    date_rangeTime Frame:
    Up to 9 weeks
  • Frequency of TEAEs in part B
    date_rangeTime Frame:
    Up to 6 weeks
  • Severity of TEAEs in part B
    date_rangeTime Frame:
    Up to 6 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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