Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04510987
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2020-07-30
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000626-25 | EUDRACT_NUMBER | None | None |