Trials / Terminated
TerminatedNCT04802837
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Summit Therapeutics · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ridinilazole | Ridinilazole 200mg dosed BID for 10 days. |
| DRUG | Vancomycin | Vancomycin 125mg dosed QID for 10 days. |
Timeline
- Start date
- 2021-05-19
- Primary completion
- 2021-09-17
- Completion
- 2022-09-28
- First posted
- 2021-03-17
- Last updated
- 2023-08-21
- Results posted
- 2023-08-21
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04802837. Inclusion in this directory is not an endorsement.