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Completed

NCT Number: NCT04008186

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

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.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omaveloxolone

Drug

50 mg capsules

Other names: RTA 408

Midazolam oral solution

Drug

2 mg/mL oral solution

Repaglinide 1 MG

Drug

1 mg tablet

MetFORMIN 500 Mg Oral Tablet

Drug

500 mg tablet

Rosuvastatin

Drug

10 mg tablet

Digoxin tablet

Drug

0.25 mg tablet

Gemfibrozil Tablets

Drug

600 mg tablet

Itraconazole capsule

Drug

100 mg capsule

Verapamil Pill

Drug

120 mg tablet

Primary outcomes

  1. Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)

    Time frame: 28 days

    Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax).

  2. Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)

    Time frame: 28 days

    Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine area under the curve (AUC).

  3. Part 2 - Maximum concentration (Cmax) of omaveloxolone

    Time frame: 23 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).

  4. Part 2 - Area under the omaveloxolone concentration-time curve (AUC)

    Time frame: 23 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).

  5. Part 3 - Maximum concentration (Cmax) of omaveloxolone

    Time frame: 23 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).

  6. Part 3 - Area under the omaveloxolone concentration-time curve (AUC)

    Time frame: 28 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).

  7. Part 4 - Maximum concentration (Cmax) of omaveloxolone

    Time frame: 23 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).

  8. Part 4 - Area under the omaveloxolone concentration-time curve (AUC)

    Time frame: 28 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Covance

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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