Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486625
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2020-07-22
Brief Title:
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN OPEN-LABEL PARALLEL-GROUP PHARMACOKINETIC STUDY OF MULTIPLE INTRAVENOUS DOSES OF AZTREONAM AND AVIBACTAM IN SUBJECTS WITH SEVERE RENAL IMPAIRMENT AND NORMAL RENAL FUNCTION
Status:
COMPLETED
Status Verified Date:
2022-09
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:
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK safety and tolerability of Aztreonam-Avibactam Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modellingsimulation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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