Healthy Adult SubjectsPhase 1NCT05909644
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
A Phase 1 study testing Omaveloxolone and Efavirenz in people with Healthy Adult Subjects, run by Biogen at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Omaveloxolone and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 30 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
- Conditions
- Healthy Adult Subjects
- Being tested
- Omaveloxolone, Efavirenz
- Keywords
- omaveloxolone, DDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmaveloxoloneDrug
Also called RTA 408
Omaveloxolone Capsules, 150 mg, administered orally
EfavirenzDrug
Efavirenz Tablet, 600 mg, administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) | Experimental | 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 Receives: Drug: Omaveloxolone; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 Jul 2023
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Q2 Solutions, Altasciences Company Inc.
- Responsible party
- Sponsor
- Investigators
- Michelle Valentine, DO, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909644
- Sponsor's protocol ID
- 408-C-2202
- Status last verified
- May 2025
- First submitted
- 8 Jun 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05909644
- Acronym / sponsor ID
- 408-C-2202
- Conditions
- Healthy Adult Subjects
- Keywords
- omaveloxolone, DDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Celerion, Q2 Solutions, Altasciences Company Inc.
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) | Experimental | Drug: Omaveloxolone, Drug: EfavirenzPeriod 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmaveloxoloneAlso: RTA 408Omaveloxolone Capsules, 150 mg, administered orally | Drug | Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) |
| EfavirenzEfavirenz Tablet, 600 mg, administered orally once daily | Drug | Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) |
Primary outcome
Maximum concentration (Cmax) of omaveloxolone
Time frame: 43 days
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.
Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone
Time frame: 43 days
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.
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone
Time frame: 43 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Healthy Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Valentine, DO principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omaveloxolone and Efavirenz in people with Healthy Adult Subjects, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) of omaveloxolone (time frame: 43 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.