Completed PHASE1 INTERVENTIONAL 4-arm 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

Sponsor: Biogen

Interventions Digoxin tablet Gemfibrozil Tablets Itraconazole capsule MetFORMIN 500 Mg Oral Tablet Midazolam oral solution Omaveloxolone Repaglinide 1 MG Rosuvastatin Verapamil Pill

Updated 8 times since 2019 Last updated: May 26, 2025 Started: Jun 14, 2019 Primary completion: Aug 18, 2019 Completion: Aug 28, 2019

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy Adult Subjects and is currently completed. Biogen leads this study, which shows 8 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Jun 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Jun 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Mar 2024 — Jul 2024 [monthly]

Completed PHASE1
Nov 2023 — Mar 2024 [monthly]

Completed PHASE1

▶ Show 3 earlier versions

Jan 2021 — Nov 2023 [monthly]

Completed PHASE1
Feb 2020 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Aug 2019 — Feb 2020 [monthly]

Recruiting PHASE1

First recorded

Jun 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Biogen
Covance

Data source: Biogen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Dallas, United States