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OpenTrials
Completed

NCT Number: NCT04510987

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")

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Tablet, oral

BAY2433334 on dialysis treatment day

Other

Tablet, oral

Primary outcomes

  1. Cmax

    Time frame: Pre-dose until 96 hours after dosing

    maximum observed drug concentration in measured matrix after single dose administration

  2. AUC

    Time frame: Pre-dose until 96 hours after dosing

    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

  3. Cmax,u

    Time frame: Pre-dose until 96 hours after dosing

    maximum unbound drug concentration in plasma after single dose administration

  4. AUCu

    Time frame: Pre-dose until 96 hours after dosing

    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

Secondary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs)

    Time frame: Up to 3 days after last study medication

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2020
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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