NCT04008186

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

A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	Omaveloxolone	50 mg capsules
DRUG	Midazolam oral solution	2 mg/mL oral solution
DRUG	Repaglinide 1 MG	1 mg tablet
DRUG	MetFORMIN 500 Mg Oral Tablet	500 mg tablet
DRUG	Rosuvastatin	10 mg tablet
DRUG	Digoxin tablet	0.25 mg tablet
DRUG	Gemfibrozil Tablets	600 mg tablet
DRUG	Itraconazole capsule	100 mg capsule
DRUG	Verapamil Pill	120 mg tablet

Timeline

• Start date: 2019-06-14
• Primary completion: 2019-08-18
• Completion: 2019-08-28
• First posted: 2019-07-05
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study