Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-31 @ 4:54 AM
Study NCT ID:
NCT01318551
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Investigation of Pharmacokinetics, Safety, Tolerability, and Pharmacodynamic Effects of BAY85-3934 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 20 mg and 40 mg (Optional) BAY 85-3934 Administered as Tablets in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Status:
COMPLETED
Status Verified Date:
2021-01
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:
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-000055-16 | EUDRACT_NUMBER | None | View |