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")

NCT04510987 | Completed Phase 1

• 2 other identifiers: 197712020-000626-25
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Renal impairment; Hemodialysis

Outcome Measures

Primary Outcomes (4)

• Cmax

  maximum observed drug concentration in measured matrix after single dose administration

  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

  Pre-dose until 96 hours after dosing

• Cmax,u

  maximum unbound drug concentration in plasma after single dose administration

  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

  Pre-dose until 96 hours after dosing

Secondary Outcomes (1)

• Number of participants with treatment emergent adverse events (TEAEs)

  Up to 3 days after last study medication

Study Arms (2)

Experimental: Treatment 1

EXPERIMENTAL

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.

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

Experimental: Treatment 2

EXPERIMENTAL

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

Other: BAY2433334 on dialysis treatment day

Interventions

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

Tablet, oral

Experimental: Treatment 1

BAY2433334 on dialysis treatment day OTHER

Tablet, oral

Experimental: Treatment 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 12, 2020
• Study Start: August 12, 2020
• Primary Completion: September 13, 2021
• Study Completion: December 15, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

DE (1)