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

NCT ID: NCT04008186

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-14
• Study Completion Date: 2019-08-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omaveloxolone and Multiple Drugs (Part 1)

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

Group Type: EXPERIMENTAL

Omaveloxolone

Intervention Type: DRUG

50 mg capsules

Midazolam oral solution

Intervention Type: DRUG

2 mg/mL oral solution

Repaglinide 1 MG

Intervention Type: DRUG

1 mg tablet

MetFORMIN 500 Mg Oral Tablet

Intervention Type: DRUG

500 mg tablet

Rosuvastatin

Intervention Type: DRUG

10 mg tablet

Digoxin tablet

Intervention Type: DRUG

0.25 mg tablet

Omaveloxolone & Gemfibrozil (Part 2)

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

Group Type: EXPERIMENTAL

Omaveloxolone

Intervention Type: DRUG

50 mg capsules

Gemfibrozil Tablets

Intervention Type: DRUG

600 mg tablet

Omaveloxolone and Itraconazole (Part 3)

Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18.

Group Type: EXPERIMENTAL

Omaveloxolone

Intervention Type: DRUG

50 mg capsules

Itraconazole capsule

Intervention Type: DRUG

100 mg capsule

Omaveloxolone and Verapamil (Part 4)

Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18.

Group Type: EXPERIMENTAL

Omaveloxolone

Intervention Type: DRUG

50 mg capsules

Verapamil Pill

Intervention Type: DRUG

120 mg tablet

Interventions

Omaveloxolone

50 mg capsules

Intervention Type: DRUG

Midazolam oral solution

2 mg/mL oral solution

Intervention Type: DRUG

Repaglinide 1 MG

1 mg tablet

Intervention Type: DRUG

MetFORMIN 500 Mg Oral Tablet

500 mg tablet

Intervention Type: DRUG

Rosuvastatin

10 mg tablet

Intervention Type: DRUG

Digoxin tablet

0.25 mg tablet

Intervention Type: DRUG

Gemfibrozil Tablets

600 mg tablet

Intervention Type: DRUG

Itraconazole capsule

100 mg capsule

Intervention Type: DRUG

Verapamil Pill

120 mg tablet

Intervention Type: DRUG

Other Intervention Names

RTA 408

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Zon, MD

Role: PRINCIPAL_INVESTIGATOR

Covance CRU Inc.

Locations

Covance Clinical Research Unit (CRU) Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

408-C-1806

Identifier Type: -

Identifier Source: org_study_id