drugset / Trial / NCT04008186

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

NCT04008186

Phase 1 Completed 61 enrolled Biogen Covance · collab
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

EvaluationDrugModalityDoseRoute
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.