An Open-label DDI Study of Omaveloxolone in Healthy Subjects

Study Overview
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Brief Summary
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This is an open-label, single-sequence, 2-period crossover study in healthy subjects. In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects. Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).

Detailed Description
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This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.

Official Title
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A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: Omaveloxolone
* Drug: Efavirenz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening. BMI at screening between 18.0 and 32.0 kg/m2 (inclusive) 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: 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). Use of any prescription medication before the first study drug administration (within 14 days before initial study drug administration or within 5 half-lives of the prescription medication, whichever is longer), and until after the last protocol-specified blood sample is prohibited, other than use of hormonal contraception. 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. Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines. History of drug or alcohol abuse in the last 6 months Positive hepatitis panel and/or positive human immunodeficiency virus test. Presence of hypotension (diastolic blood pressure ≤50 mmHg, systolic blood pressure ≤90 mmHg) or hypertension (diastolic blood pressure ≥ 140 mmHg, systolic blood pressure ≥ 90 mmHg) Blood donation (excluding plasma donation) within 56 days prior to screening and plasma donation within 7 days before screening. Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2)<br>Period 1 (Day 1 - 15): Omaveloxolone Capsules, 150 mg, administered orally in a single dose on Day 1 Period 2 (Day 15 - 43): Efavirenz Tablet, 600 mg, administered orally once daily from Day 15 - Day 42 and Omaveloxolone Capsules, 150 mg, administered orally in a single dose on Day 29 | Drug: Omaveloxolone<br>* Omaveloxolone Capsules, 150 mg, administered orally<br>* Other names: RTA 408;Drug: Efavirenz<br>* Efavirenz Tablet, 600 mg, administered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) of omaveloxolone | Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study. | 43 days | 
| Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone | Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study. | 43 days | 
| Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone | Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study. | 43 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omaveloxolone, DDI