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Completed

NCT Number: NCT03244462

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

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRAHealthSciences

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BAY1834845

Drug

Single oral dose (IR [immediate release] tablets)

methotrexate

Drug

Single dose of commercially available MTX

Primary outcomes

  1. 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

    Time frame: Multiple timepoints up to day 7

    in study part A

  2. Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state

    Time frame: Multiple timepoints up to day 7

    in study part A

  3. Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration

    Time frame: Multiple timepoints up to day 7

    in study part A

  4. Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration

    Time frame: Multiple timepoints up to day 7

    in study part A

  5. Absolute oral bioavailability (F) of BAY1834845 in the fasted state

    Time frame: Multiple timepoints up to day 7

    in study part A

  6. AUC of methotrexate in plasma in presence/absence of BAY1834845

    Time frame: Multiple timepoints up to day 2

    in study part B

  7. Cmax of methotrexate in plasma in presence/absence of BAY1834845

    Time frame: Multiple timepoints up to day 2

    in study part B

Secondary outcomes

  1. Frequency of Treatment Emergent Adverse Events (TEAEs) in part A

    Time frame: Up to 9 weeks

  2. Severity of TEAEs in part A

    Time frame: Up to 9 weeks

  3. Frequency of TEAEs in part B

    Time frame: Up to 6 weeks

  4. Severity of TEAEs in part B

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2017
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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