Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665037
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2020-12-09
Brief Title:
Posaconazole MK-5592 Intravenous and Oral in Children 2 Years With Invasive Fungal Infection MK-5592-127
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 2 Open-Label Single-Arm Sequential-Panel Study to Evaluate the Pharmacokinetics Safety and Tolerability of Posaconazole POS MK-5592 Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible Probable or Proven Invasive Fungal Infection
Status:
RECRUITING
Status Verified Date:
2024-10
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 estimate the pharmacokinetics PK of posaconazole POS MK-5592 intravenous IV and powder for oral suspension PFS formulations in pediatric participants 2 years of age with invasive fungal infection IFI
Detailed Description:
There are 2 panels in this study In Panel A POS IV will be evaluated in 8 participants In Panel B both POS IV and POS PFS will be evaluated in 14 participants including 6 who are 3 months of age and 5 who transition to the PFS formulation of POS
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 |
|---|---|---|---|
| 2019-003842-34 | EUDRACT_NUMBER | EU CT | None |
| MK-5592-127 | OTHER | None | None |
| PHRR230411-005589 | REGISTRY | None | None |
| 2023-505613-24 | REGISTRY | None | None |