Healthy Adult SubjectsPhase 1NCT04008186
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
A Phase 1 study testing Omaveloxolone, Midazolam oral solution and Repaglinide 1 MG in people with Healthy Adult Subjects, run by Biogen at 1 site in United States.
Trial summary
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters. 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, Midazolam oral solution and Repaglinide 1 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 28 Aug 2019
- 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
- Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:
- Males or females, of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight >50 kg.
- In good health.
- 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
- Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:
- 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).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- History of alcoholism or drug/chemical abuse within 2 years prior to Check in (Day 1).
- Abnormal laboratory values considered clinically significant by the investigator
Show all 15Show fewer
- 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.
- Pulse rate <50 bpm or systolic blood pressure <110 mmHg.
- Alcohol consumption of >21 units per week for males and >14 units for females.
- Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half lives (if known), whichever is longer, prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
- Have previously completed or withdrawn from this study or any other study investigating omaveloxolone, and have previously received the investigational product.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit (CRU) Inc.
Dallas, Texas, 75247
About this study
Official title: A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
- Conditions
- Healthy Adult Subjects
- Being tested
- Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin
- Keywords
- RTA 408, RTA 408 capsules, omaveloxolone, omaveloxolone capsules, 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
50 mg capsules
Midazolam oral solutionDrug
2 mg/mL oral solution
Repaglinide 1 MGDrug
1 mg tablet
MetFORMIN 500 Mg Oral TabletDrug
500 mg tablet
RosuvastatinDrug
10 mg tablet
Digoxin tabletDrug
0.25 mg tablet
Gemfibrozil TabletsDrug
600 mg tablet
Itraconazole capsuleDrug
100 mg capsule
Verapamil PillDrug
120 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Omaveloxolone and Multiple Drugs (Part 1) | Experimental | Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27 Receives: Drug: Omaveloxolone; Drug: Midazolam oral solution; Drug: Repaglinide 1 MG; Drug: MetFORMIN 500 Mg Oral Tablet; Drug: Rosuvastatin; Drug: Digoxin tablet |
| Omaveloxolone & Gemfibrozil (Part 2) | Experimental | Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 600 mg gemfibrozil (twice daily) on Days 10 to 18 Receives: Drug: Omaveloxolone; Drug: Gemfibrozil Tablets |
| Omaveloxolone and Itraconazole (Part 3) | Experimental | Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18. Receives: Drug: Omaveloxolone; Drug: Itraconazole capsule |
| Omaveloxolone and Verapamil (Part 4) | Experimental | Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18. Receives: Drug: Omaveloxolone; Drug: Verapamil Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax).
Measured: 28 days
Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine area under the curve (AUC).
Measured: 28 days
Part 2 - Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Measured: 23 days
Part 2 - Area under the omaveloxolone concentration-time curve (AUC)
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Measured: 23 days
Part 3 - Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Measured: 23 days
Part 3 - Area under the omaveloxolone concentration-time curve (AUC)
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Measured: 28 days
Part 4 - Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Measured: 23 days
Part 4 - Area under the omaveloxolone concentration-time curve (AUC)
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start14 Jun 2019
- Primary completion18 Aug 2019
- Study completion28 Aug 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Jennifer Zon, MD, Principal investigator, Covance CRU Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008186
- Sponsor's protocol ID
- 408-C-1806
- Status last verified
- May 2025
- First submitted
- 2 Jul 2019
- 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 Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04008186
- Acronym / sponsor ID
- 408-C-1806
- Conditions
- Healthy Adult Subjects
- Keywords
- RTA 408, RTA 408 capsules, omaveloxolone, omaveloxolone capsules, DDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 5 Jul 2019 (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 study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Omaveloxolone and Multiple Drugs (Part 1) | Experimental | Drug: Omaveloxolone, Drug: Midazolam oral solution, Drug: Repaglinide 1 MG, Drug: MetFORMIN 500 Mg Oral Tablet, Drug: Rosuvastatin, Drug: Digoxin tabletSingle oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27 |
| Omaveloxolone & Gemfibrozil (Part 2) | Experimental | Drug: Omaveloxolone, Drug: Gemfibrozil TabletsSingle oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 600 mg gemfibrozil (twice daily) on Days 10 to 18 |
| Omaveloxolone and Itraconazole (Part 3) | Experimental | Drug: Omaveloxolone, Drug: Itraconazole capsuleSingle oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18. |
| Omaveloxolone and Verapamil (Part 4) | Experimental | Drug: Omaveloxolone, Drug: Verapamil PillSingle oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:
- Males or females, of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight >50 kg.
- In good health.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Key exclusion criteria (15 listed)
- Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:
- 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).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- History of alcoholism or drug/chemical abuse within 2 years prior to Check in (Day 1).
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 40850 mg capsules | Drug | Omaveloxolone & Gemfibrozil (Part 2), Omaveloxolone and Itraconazole (Part 3), Omaveloxolone and Multiple Drugs (Part 1), Omaveloxolone and Verapamil (Part 4) |
| Midazolam oral solution2 mg/mL oral solution | Drug | Omaveloxolone and Multiple Drugs (Part 1) |
| Repaglinide 1 MG1 mg tablet | Drug | Omaveloxolone and Multiple Drugs (Part 1) |
| MetFORMIN 500 Mg Oral Tablet500 mg tablet | Drug | Omaveloxolone and Multiple Drugs (Part 1) |
| Rosuvastatin10 mg tablet | Drug | Omaveloxolone and Multiple Drugs (Part 1) |
| Digoxin tablet0.25 mg tablet | Drug | Omaveloxolone and Multiple Drugs (Part 1) |
| Gemfibrozil Tablets600 mg tablet | Drug | Omaveloxolone & Gemfibrozil (Part 2) |
| Itraconazole capsule100 mg capsule | Drug | Omaveloxolone and Itraconazole (Part 3) |
| Verapamil Pill120 mg tablet | Drug | Omaveloxolone and Verapamil (Part 4) |
Primary outcome
Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
Time frame: 28 days
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax).
Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
Time frame: 28 days
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine area under the curve (AUC).
Part 2 - Maximum concentration (Cmax) of omaveloxolone
Time frame: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Part 2 - Area under the omaveloxolone concentration-time curve (AUC)
Time frame: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Part 3 - Maximum concentration (Cmax) of omaveloxolone
Time frame: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Part 3 - Area under the omaveloxolone concentration-time curve (AUC)
Time frame: 28 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Part 4 - Maximum concentration (Cmax) of omaveloxolone
Time frame: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Part 4 - Area under the omaveloxolone concentration-time curve (AUC)
Time frame: 28 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
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.
Jennifer Zon, MD principal investigator
Covance CRU Inc.
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, Midazolam oral solution and Repaglinide 1 MG 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 6 inclusion and 15 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?
Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin) (time frame: 28 days). The study lists 8 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.