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")

Prevention of Thromboembolic Events Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510987
• Other study ID #: 19771
• Secondary ID: 2020-000626-25
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 15, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prevention of Thromboembolic Events
• Renal Insufficiency
• Thromboembolism

Intervention

Drug:
• BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5
Tablet, oral

Other:
• BAY2433334 on dialysis treatment day
Tablet, oral

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	maximum observed drug concentration in measured matrix after single dose administration	Pre-dose until 96 hours after dosing
Primary	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-8) >20% of AUC	Pre-dose until 96 hours after dosing
Primary	Cmax,u	maximum unbound drug concentration in plasma after single dose administration	Pre-dose until 96 hours after dosing
Primary	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-8) >20% of AUC	Pre-dose until 96 hours after dosing
Secondary	Number of participants with treatment emergent adverse events (TEAEs)		Up to 3 days after last study medication