Trials / Completed
CompletedNCT05527834
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Basilea Pharmaceutica · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VNRX-7145 | Single oral dose |
| DRUG | Ceftibuten | Single oral dose |
Timeline
- Start date
- 2022-09-13
- Primary completion
- 2023-02-06
- Completion
- 2023-02-10
- First posted
- 2022-09-06
- Last updated
- 2025-12-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05527834. Inclusion in this directory is not an endorsement.