drugset / Trial / NCT04008186
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
Timeline
- Start
- 2019-06-14
- Primary completion
- 2019-08-18
- Completion
- 2019-08-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Gemfibrozil | Small molecule | 600 mg | Oral |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Omaveloxolone | Small molecule | 150 mg | Oral |
| Subject | Repaglinide | Small molecule | 1 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | Verapamil | Other / unclassified | 120 mg | Oral |
Indications
No indication recorded.