Trials / Completed
CompletedNCT03332732
VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Venatorx Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VNRX-5133 | β-lactamase inhibitor |
| DRUG | VNRX-5022 | Approved β-lactam antibiotic |
| DRUG | Metronidazole | Approved antibiotic and antiprotozoal medication |
| DRUG | Placebo | Placebo (matching VNRX-5133 + VNRX-5022) |
Timeline
- Start date
- 2017-10-24
- Primary completion
- 2017-12-20
- Completion
- 2017-12-20
- First posted
- 2017-11-06
- Last updated
- 2018-10-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03332732. Inclusion in this directory is not an endorsement.