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")
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Schleswig-Holstein
-
Kiel, Schleswig-Holstein, Germany, 24105
- CRS Clinical-Research-Services Kiel GmbH
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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.
|
Tablet, oral
|
|
Experimental: Experimental: Treatment 2
Participants in Group 5 will receive a single dose of BAY2433334 on a day with dialysis treatment.
|
Tablet, oral
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cmax
Time Frame: Pre-dose until 96 hours after dosing
|
maximum observed drug concentration in measured matrix after single dose administration
|
Pre-dose until 96 hours after dosing
|
|
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
|
Pre-dose until 96 hours after dosing
|
|
Cmax,u
Time Frame: Pre-dose until 96 hours after dosing
|
maximum unbound drug concentration in plasma after single dose administration
|
Pre-dose until 96 hours after dosing
|
|
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
|
Pre-dose until 96 hours after dosing
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: Up to 3 days after last study medication
|
Up to 3 days after last study medication
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 19771
- 2020-000626-25 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prevention of Thromboembolic Events
-
NCT05471830CompletedAtrial Fibrillation | Prevention of Thromboembolic Events
-
NCT01344954CompletedProphylaxis of Venous Thromboembolic Events
-
NCT05419635CompletedAtrial Fibrillation | Hepatic Impairment | Acute Myocardial Infarction | Prevention of Thromboembolic Events | Non-cardioembolic Ischemic Stroke
-
NCT04055350Active, not recruitingPrevention of In-hospital Adverse Events
-
NCT06562985CompletedHealthy Volunteers | Acute Venous and Arterial Thrombotic and Thromboembolic Events
-
NCT06619483CompletedHealthy Volunteers | Acute Venous and Arterial Thrombotic and Thromboembolic Events
-
NCT06100380Completed
-
NCT00786474CompletedAtrial Fibrillation | Arterial Thromboembolic Events
-
NCT04523220CompletedHemodialysis | End-stage Renal Disease | Hemodiafiltration | Prevention of Thromboembolic Events
Clinical Trials on BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5
-
NCT01099566CompletedSepsis | Healthy Volunteers
-
NCT05923411Completed
-
NCT01345175Completed
-
NCT07134478Active, not recruiting
-
NCT01639690Active, not recruitingConfirmed Diagnosis of ß-thalassemia Major
-
NCT07130227CompletedMindfulness Training
-
NCT01431898Completed
-
NCT00596154CompletedNon-Hodgkin's Lymphoma | CNS Lymphoma | CNS Brain Cancer
-
NCT02600741Completed