Clinical trial NCT03244462: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-08-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: 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
timeFrame: Multiple timepoints up to day 7
measure: Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
timeFrame: Multiple timepoints up to day 7
measure: Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
timeFrame: Multiple timepoints up to day 7
measure: Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
timeFrame: Multiple timepoints up to day 7
measure: Absolute oral bioavailability (F) of BAY1834845 in the fasted state
timeFrame: Multiple timepoints up to day 7
measure: AUC of methotrexate in plasma in presence/absence of BAY1834845
timeFrame: Multiple timepoints up to day 2
measure: Cmax of methotrexate in plasma in presence/absence of BAY1834845
timeFrame: Multiple timepoints up to day 2
Secondary outcomes:
measure: Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
timeFrame: Up to 9 weeks
measure: Severity of TEAEs in part A
timeFrame: Up to 9 weeks
measure: Frequency of TEAEs in part B
timeFrame: Up to 6 weeks
measure: Severity of TEAEs in part B
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRAHealthSciences
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: