drugset / Trial / NCT05927649
A TQTc Study for Omaveloxolone
RandomizedCrossoverTriple-blindBasic science
Summary
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.
Timeline
- Start
- 2023-07-11
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | Omaveloxolone | Small molecule | 450 mg | — |
Indications
No indication recorded.