Health Adult SubjectsPhase 1NCT05927649
A TQTc Study for Omaveloxolone
A Phase 1 study testing Omaveloxolone and Moxifloxacin in people with Health Adult Subjects, run by Biogen at 1 site in United States.
Trial summary
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- Omaveloxolone and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 1 Sep 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
- History of clinically significant drug allergies, including allergies to any of the components of the study drugs (omaveloxolone and moxifloxacin) and/or clinically significant food allergies as determined by the investigator.
- Subject has an ECG abnormality, including corrected QT interval (QTc)> 450 msec for males, and > 460 msec for females, HR < 45 bpm or > 100 bpm after 5 minutes in supine position, PR interval > 220 msec, or QRS interval > 110 msec.
- Subject has allergy to band aids, adhesive dressing, or medical tape.
- Subject has hypotension (systolic blood pressure blood pressure [BP] ≤ 90 mmHg, diastolic BP ≤ 50 mmHg), or hypertension (systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg) at screening.
- Subject has history of prolonged QTc, cardiac arrhythmia, or first-degree relatives with congenital Long QT syndrome or unexplained sudden death in young age.
- Subject has a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), transient ischemic attack (TIA), or neurological disorder.
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- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator.
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- Requirement for any over the counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis
- Use of any medications (over the counter and/or prescription medication), vitamins, and/or herbal supplements, within the 14-days prior to study drug administration or within 5 halflives (if known), whichever is longer
- History of drug or alcohol abuse in the last 6 months as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
- Positive test result for drugs of abuse, alcohol, or cotinine at screening or Day -1.
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibodies, or HIV antibodies at screening.
- Positive test result for COVID-19 at Day -1.
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days before screening or plasma donation within 7 days before screening.
- Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days before study drug administration.
- Consumption of alcohol within 72 hours before study drug administration.
- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, Seville oranges, or Seville orange products within the 72-hour period before study drug administration.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
- Previous enrollment in any clinical study involving omaveloxolone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc Interval
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.
- Conditions
- Health Adult Subjects
- Being tested
- Omaveloxolone, Moxifloxacin
- Keywords
- C-QTc, omaveloxolone, TWTc, moxifloxacin
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
MoxifloxacinDrug
Moxifloxacin capsules
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment A (Period 1 from Day 1 - 15), Treatment B (Period 2 from Day 15 - 29), and Treatment C(Period 3 from Day 29 -32) Receives: Drug: Omaveloxolone; Drug: Moxifloxacin |
| Sequence BAC | Experimental | Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment B (Period 1 from Day 1-15), Treatment A (Period 2 from Day 15 - 29, and Treatment C (Period 3 from Day 29 to 32) Receives: Drug: Omaveloxolone; Drug: Moxifloxacin |
| Sequence ACB | Experimental | Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment A (Period 1 from Day 1-15), Treatment C (Period 2 from Day 15 -18), and Treatment B (Period 3from Day 18 - 32) Receives: Drug: Omaveloxolone; Drug: Moxifloxacin |
| Sequence BCA | Experimental | Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment B (Period 1 from Day 1 - 15), Treatment C (Period 2 from Day 15 to 18), and Treatment A (Period 3 from Day 18 - 32) Receives: Drug: Omaveloxolone; Drug: Moxifloxacin |
| Sequence CAB | Experimental | Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment C (Period 1 from Day 1 - 4), Treatment A (Period 2 from Day 4 - 18), and Treatment B (Period 3 from Day 18 - 32) Receives: Drug: Omaveloxolone; Drug: Moxifloxacin |
| Sequence CBA | Experimental | Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment C (Period 1 from Day 1 - 4), Treatment B (Period 2 from Day 4 - 18), and Treatment A (Period 3 from Day 18 - 32) Receives: Drug: Omaveloxolone; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in placebo-corrected QTcF (∆∆QTcF)
The relationship between ∆QTcF and omaveloxolone and its metabolites, M17 and M22 plasma concentrations will be investigated by a linear mixed effects modeling approach with ∆ QTcF as the dependent variable, time-matched concentration of omaveloxolone and its metabolites as a continuous covariate (ie, 0 for placebo), and centered baseline QTcF as an additional covariate, treatment (active = 1; or placebo = 0) and time as categorical factors, and a random intercept and slope per subject.
Measured: At Day 1 of each period, which is 14 days for both Treatment A and Treatment B and 4 days for Treatment C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Jul 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Q2 Solutions
- Responsible party
- Sponsor
- Investigators
- Michelle Valentine, DO, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927649
- Sponsor's protocol ID
- 408-C-2201
- Status last verified
- May 2025
- First submitted
- 21 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/
Publications
Zahir H, Murai M, Wu L, Valentine M, Hynes SM. Effect of a Supratherapeutic Dose of Omaveloxolone on the Corrected QT Interval in Healthy Participants: A Randomized, Double-Blind, Placebo- and Active-Controlled, Three-Way Crossover Study. Clin Transl Sci. 2025 Feb;18(2):e70139. doi: 10.1111/cts.70139.
PubMed 39976332
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 Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc Interval
- ClinicalTrials.gov ID
- NCT05927649
- Acronym / sponsor ID
- 408-C-2201
- Conditions
- Health Adult Subjects
- Keywords
- C-QTc, omaveloxolone, TWTc, moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Celerion, Q2 Solutions
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Jul 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 a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: Omaveloxolone, Drug: MoxifloxacinSubjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment A (Period 1 from Day 1 - 15), Treatment B (Period 2 from Day 15 - 29), and Treatment C(Period 3 from Day 29 -32) |
| Sequence BAC | Experimental | Drug: Omaveloxolone, Drug: MoxifloxacinSubjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment B (Period 1 from Day 1-15), Treatment A (Period 2 from Day 15 - 29, and Treatment C (Period 3 from Day 29 to 32) |
| Sequence ACB | Experimental | Drug: Omaveloxolone, Drug: MoxifloxacinSubjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment A (Period 1 from Day 1-15), Treatment C (Period 2 from Day 15 -18), and Treatment B (Period 3from Day 18 - 32) |
| Sequence BCA | Experimental | Drug: Omaveloxolone, Drug: MoxifloxacinSubjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment B (Period 1 from Day 1 - 15), Treatment C (Period 2 from Day 15 to 18), and Treatment A (Period 3 from Day 18 - 32) |
| Sequence CAB | Experimental | Drug: Omaveloxolone, Drug: MoxifloxacinSubjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment C (Period 1 from Day 1 - 4), Treatment A (Period 2 from Day 4 - 18), and Treatment B (Period 3 from Day 18 - 32) |
| Sequence CBA | Experimental | Drug: Omaveloxolone, Drug: MoxifloxacinSubjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment C (Period 1 from Day 1 - 4), Treatment B (Period 2 from Day 4 - 18), and Treatment A (Period 3 from Day 18 - 32) |
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 (21 listed)
- History of clinically significant drug allergies, including allergies to any of the components of the study drugs (omaveloxolone and moxifloxacin) and/or clinically significant food allergies as determined by the investigator.
- Subject has an ECG abnormality, including corrected QT interval (QTc)> 450 msec for males, and > 460 msec for females, HR < 45 bpm or > 100 bpm after 5 minutes in supine position, PR interval > 220 msec, or QRS interval > 110 msec.
- Subject has allergy to band aids, adhesive dressing, or medical tape.
- Subject has hypotension (systolic blood pressure blood pressure [BP] ≤ 90 mmHg, diastolic BP ≤ 50 mmHg), or hypertension (systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg) at screening.
- Subject has history of prolonged QTc, cardiac arrhythmia, or first-degree relatives with congenital Long QT syndrome or unexplained sudden death in young age.
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 | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| MoxifloxacinMoxifloxacin capsules | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
Primary outcome
Change from baseline in placebo-corrected QTcF (∆∆QTcF)
Time frame: At Day 1 of each period, which is 14 days for both Treatment A and Treatment B and 4 days for Treatment C
The relationship between ∆QTcF and omaveloxolone and its metabolites, M17 and M22 plasma concentrations will be investigated by a linear mixed effects modeling approach with ∆ QTcF as the dependent variable, time-matched concentration of omaveloxolone and its metabolites as a continuous covariate (ie, 0 for placebo), and centered baseline QTcF as an additional covariate, treatment (active = 1; or placebo = 0) and time as categorical factors, and a random intercept and slope per subject.
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.
- Derived from this study: PubMed 39976332Zahir H, Murai M, Wu L, Valentine M, Hynes SM. Effect of a Supratherapeutic Dose of Omaveloxolone on the Corrected QT Interval in Healthy Participants: A Randomized, Double-Blind, Placebo- and Active-Controlled, Three-Way Crossover Study. Clin Transl Sci. 2025 Feb;18(2):e70139. doi: 10.1111/cts.70139.
- 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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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 Moxifloxacin in people with Health 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 21 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?
Change from baseline in placebo-corrected QTcF (∆∆QTcF) (time frame: At Day 1 of each period, which is 14 days for both Treatment A and Treatment B and 4 days for Treatment C). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927649, which also lists 1 linked publication.
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.