Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-07 @ 10:39 PM
Study NCT ID:
NCT05527834
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
Sponsor:
Basilea Pharmaceutica
Organization:
Study Overview
Official Title:
VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.
Status:
COMPLETED
Status Verified Date:
2025-11
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 is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 272201600029C-P00017-9999-1 | NIH | None | https://reporter.nih.gov/quic… | View |