check_circleStudy Completed

Prevention of thromboembolic events,

Bayer Identifier:

19771

ClinicalTrials.gov Identifier:

NCT04510987

EudraCT Number:

2020-000626-25

EU CT Number:

Not Available
Study to assess the safety, tolerability, effects on the body, absorption, distribution and elimination of 25 mg BAY2433334 in renal impairment including renal replacement therapy (“dialysis”)

Trial purpose

BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the blood stream to plug another vessel. Renal impairment which co-occurs in elderly and patients with heart attack, irregular heart beat or stroke is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study is to learn more about the safety of BAY2433334, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 25 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - All participants: ≥18 years, male or female (non-WOCBP only), BMI 18-35 kg/m² (inclusive); no increased risk of bleeding or common causes of bleeding, no liver dysfunction; no CYP3A4 inhibitors/inducers;
    - Participants with reduced kidney function including those on kidney replacement therapy (“dialysis”): stable disease stratified by renal function (mild, moderate, severe, ESRD), no recent cardiovascular events;
    - Age-, gender- and weight-matched participants: normal kidney function, stable and well controlled hypertension and dyslipidemia acceptable, no medications influencing the coagulation system.
  • Subjects with renal impairment
    - Acute renal failure or active nephritis.
    - Known impaired hepatic function.
    - History of definite myocardial infarction or cerebrovascular accident within the six months prior to the screening visit.
    - History of vascular surgery or intervention (e.g., coronary artery bypass, percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing.
    - Congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring antiarrhythmic treatment.
    - Any other disease or condition which could influence the physiological metabolic turnover (e.g., endocrine diseases, severe infections).

    Age-, gender, weight matched subjects
    - History of relevant diseases of vital organs or systems (e.g., of the central nervous system or other systems or organs) with the exception of mild, well controlled hypertension, dyslipoproteinemia and thyroid disorders.

Trial summary

Enrollment Goal
48
Trial Dates
August 2020 - December 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
Asundexian (BAY2433334)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany

Primary Outcome

  • Cmax
    maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Pre-dose until 96 hours after dosing
  • AUC
    area under the concentration vs. time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
    date_rangeTime Frame:
    Pre-dose until 96 hours after dosing
  • Cmax,u
    maximum unbound drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Pre-dose until 96 hours after dosing
  • AUCu
    area under the unbound plasma concentration vs time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
    date_rangeTime Frame:
    Pre-dose until 96 hours after dosing

Secondary Outcome

  • Number of participants with treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 3 days after last study medication

Trial design

Investigation of pharmacokinetics, pharmacodynamics, safety, and tolerability of a single oral dose of 25 mg BAY 2433334 in male and female participants with different stages of renal impairment (including on dialysis), as compared to age, gender and weight matched participants in a single-center, non-randomized, non-controlled, non-blinded, group stratification design study.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2