Study Overview
This study examined the effects of a high dose of Omaveloxolone on heart rhythm in healthy adults. It was a well-structured trial involving a placebo and an active control.
Key Details
- Omaveloxolone is approved for treating Friedreich ataxia in patients aged 16 and older.
- The study involved 30 healthy participants who received different doses of Omaveloxolone (450 mg), a placebo, or moxifloxacin (400 mg).
- All doses were taken with a high-fat meal to assess their effects on heart rhythm.
Findings
- The study found that Omaveloxolone did not significantly prolong the corrected QT interval (QTc), which is important for heart health.
- All participants completed the study without any safety issues.
- The maximum concentration of Omaveloxolone was much higher than the approved dose, yet it remained safe.
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