Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877379
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2021-05-03
Brief Title:
VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
Sponsor:
Venatorx Pharmaceuticals Inc
Organization:
Venatorx Pharmaceuticals Inc
Study Overview
Official Title:
VNRX-7145-102 A Randomized Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics PK of VNRX-7145 and VNRX-5024 Ceftibuten in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2022-06
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 will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 ceftibuten when administered as single agents and with co-administration in a single dose cross-over design in Part 1 In Part 2 subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days VNRX-7145 and VNRX-5024 ceftibuten will be administered every 8 hours q8h for 10 days at 2 dose levels of VNRX-7145 in Part 3
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 |
|---|---|---|---|
| 272201600029C-P00007-9999-2 | NIH | None | httpsreporternihgovquickSearch272201600029C-P00007-9999-2 |