Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03230916
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2017-07-17
Brief Title:
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections MK-7655A-020
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 1b Open-label Single-dose Study to Evaluate the Pharmacokinetics Safety and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections
Status:
COMPLETED
Status Verified Date:
2024-01
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:
This study aims to obtain plasma pharmacokinetic PK data and characterize the PK profile of imipenem IMI cilastatin CIL and relebactam REL following administration of a single intravenous IV dose of MK-7655A a fixed ratio combination of imipenemcilastatinrelebactam hereafter referred to as IMIREL
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-7665A-020 | OTHER | None | None |
| 2016-004328-43 | EUDRACT_NUMBER | Merck | None |