Independent directory Public ClinicalTrials.gov records United States
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Showing 1–8 of 8 matching trials from the live ClinicalTrials.gov search.
Completed Phase 1 Interventional Accepts healthy volunteers

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

NCT03664453
Conditions
Healthy
Interventions
omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Cincinnati, Ohio
Completed Phase 1 Interventional Accepts healthy volunteers

An Open-label DDI Study of Omaveloxolone in Healthy Subjects

NCT05909644
Conditions
Healthy Adult Subjects
Interventions
Omaveloxolone, Efavirenz
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Tempe, Arizona
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
2 Years to 15 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Completed Phase 1Phase 2 Interventional Results available

RTA 408 Capsules in Patients With Melanoma - REVEAL

NCT02259231
Conditions
Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma
Interventions
Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg), Omaveloxolone Capsules (10 mg/capsule), Omaveloxolone Capsules (50 mg/capsule)
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
10
States / cities
Mobile, Alabama • Fayetteville, Arkansas • Aurora, Colorado + 7 more
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg, Placebo, Omaveloxolone Capsules, 20 mg, Omaveloxolone Capsules, 40 mg, Omaveloxolone Capsules, 80 mg, Omaveloxolone Capsules, 160 mg, Omaveloxolone Capsules, 300 mg, Omaveloxolone Capsules, 150 mg
Drug
Lead sponsor
Biogen
Industry
Eligibility
16 Years to 40 Years
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2025
U.S. locations
7
States / cities
Los Angeles, California • Gainesville, Florida • Tampa, Florida + 4 more
Conditions
Hepatic Impairment
Interventions
Omaveloxolone 50 mg capsules
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 70 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
3
States / cities
Tustin, California • Miami, Florida • Orlando, Florida
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT04008186
Conditions
Healthy Adult Subjects
Interventions
Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin, Digoxin tablet, Gemfibrozil Tablets, Itraconazole capsule, Verapamil Pill
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
61 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Dallas, Texas
Completed Phase 1 Interventional Accepts healthy volunteers

A Human AME Study for Omaveloxolone

NCT03931590
Conditions
Healthy Male Subjects
Interventions
[14C]-Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Madison, Wisconsin