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CompletedNCT05909644Updated May 30, 2025

An Open-label DDI Study of Omaveloxolone in Healthy Subjects

A Phase 1 interventional study of Omaveloxolone and Efavirenz in Healthy Adult Subjects, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Healthy Adult Subjects

Keywords

  • omaveloxolone
  • DDI
03

In context

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2)

    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 · Drug: Efavirenz

Interventions

  • DrugOmaveloxolone

    Omaveloxolone Capsules, 150 mg, administered orally

    Also known as: RTA 408

  • DrugEfavirenz

    Efavirenz Tablet, 600 mg, administered orally once daily

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 43 days

  2. 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.

    Time frame: 43 days

  3. 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.

    Time frame: 43 days

07

Study locations

1 site
  • Celerion, Inc.
    Tempe, Arizona 85283, United States
08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05909644
Lead sponsor
Biogen
Collaborators
Celerion, Q2 Solutions, Altasciences Company Inc.
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Jul 5, 2023
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023
Last update
May 30, 2025

Study contacts

Michelle Valentine, DO
principal investigator · Celerion

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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