CompletedNCT05927649Updated May 30, 2025

A TQTc Study for Omaveloxolone

A Phase 1 interventional study of Omaveloxolone and Moxifloxacin in Health 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 Basic science

From the registry’s dates

Primary completion was Sep 2023, 3 years 1 month ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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. 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 studied

Health Adult Subjects

Keywords

C-QTc
omaveloxolone
TWTc
moxifloxacin

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.

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:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 30 participants (actual)

Study arms

Experimental
Sequence ABC
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)
Drug: Omaveloxolone · Drug: Moxifloxacin
Experimental
Sequence BAC
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)
Drug: Omaveloxolone · Drug: Moxifloxacin
Experimental
Sequence ACB
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)
Drug: Omaveloxolone · Drug: Moxifloxacin
Experimental
Sequence BCA
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)
Drug: Omaveloxolone · Drug: Moxifloxacin
Experimental
Sequence CAB
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)
Drug: Omaveloxolone · Drug: Moxifloxacin
Experimental
Sequence CBA
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)
Drug: Omaveloxolone · Drug: Moxifloxacin

Interventions

DrugOmaveloxolone
Omaveloxolone capsules
Also known as: RTA 408
DrugMoxifloxacin
Moxifloxacin capsules

What researchers measure

Primary outcomes

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.
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

Study locations

1 site

Celerion, Inc.
Tempe, Arizona 85283, United States

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.

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 ↗

Registry details

Key details

Study ID: NCT05927649
Lead sponsor: Biogen
Collaborators: Celerion, Q2 Solutions
Responsible party: Sponsor
First posted: Jul 3, 2023
Start date: Jul 11, 2023
Primary completion: Sep 1, 2023
Completion: Sep 1, 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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Biogen

Start the discussion