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")

NCT ID: NCT04510987

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2021-12-15

Brief Summary

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.

Conditions

Prevention of Thromboembolic Events

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental: Treatment 1

Participants in Groups 1-4 and Group 6 will receive a single dose of BAY2433334 on one occasion. Participants in Group 5 will receive a single dose of BAY2433334 on a dialysis-free day.

Group Type: EXPERIMENTAL

BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5

Intervention Type: DRUG

Tablet, oral

Experimental: Treatment 2

Participants in Group 5 will receive a single dose of BAY2433334 on a day with dialysis treatment.

Group Type: EXPERIMENTAL

BAY2433334 on dialysis treatment day

Intervention Type: OTHER

Tablet, oral

Interventions

BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5

Tablet, oral

Intervention Type: DRUG

BAY2433334 on dialysis treatment day

Tablet, oral

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

2020-000626-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19771

Identifier Type: -

Identifier Source: org_study_id