ClinicalTrials.Veeva

Menu

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

Biogen logo

Biogen

Status and phase

Completed
Phase 1

Conditions

Healthy Adult Subjects

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04008186
408-C-1806

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:

  • Males or females, of any race, between 18 and 55 years of age, inclusive.
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight >50 kg.
  • In good health.
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
  • Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion criteria

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:

  • Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee).
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
  • History of alcoholism or drug/chemical abuse within 2 years prior to Check in (Day 1).
  • Abnormal laboratory values considered clinically significant by the investigator
  • Clinically significant abnormal 12 lead ECGs
  • Personal history of unexplained syncopal events, or family history of long QT syndrome or sudden unexplained death in a young person.
  • Pulse rate <50 bpm or systolic blood pressure <110 mmHg.
  • Alcohol consumption of >21 units per week for males and >14 units for females.
  • Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.
  • Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half lives (if known), whichever is longer, prior to dosing.
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
  • Have previously completed or withdrawn from this study or any other study investigating omaveloxolone, and have previously received the investigational product.
  • Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

61 participants in 4 patient groups

Omaveloxolone and Multiple Drugs (Part 1)
Experimental group
Description:
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
Treatment:
Drug: Digoxin tablet
Drug: Omaveloxolone
Drug: Midazolam oral solution
Drug: MetFORMIN 500 Mg Oral Tablet
Drug: Rosuvastatin
Drug: Repaglinide 1 MG
Omaveloxolone & Gemfibrozil (Part 2)
Experimental group
Description:
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 600 mg gemfibrozil (twice daily) on Days 10 to 18
Treatment:
Drug: Omaveloxolone
Drug: Gemfibrozil Tablets
Omaveloxolone and Itraconazole (Part 3)
Experimental group
Description:
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18.
Treatment:
Drug: Omaveloxolone
Drug: Itraconazole capsule
Omaveloxolone and Verapamil (Part 4)
Experimental group
Description:
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18.
Treatment:
Drug: Omaveloxolone
Drug: Verapamil Pill

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems