HealthyPhase 1NCT03664453
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
A Phase 1 study testing omaveloxolone in people with Healthy, run by Biogen at 1 site in United States.
Trial summary
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- omaveloxolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 20 Nov 2018
- 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
- Male or female and age is between 18 and 55 years, inclusive;
- All female subjects must have negative results for pregnancy tests performed;
- If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
- If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
- Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator.
Who cannot join
- 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;
- Recent (6-month) history of drug or alcohol abuse;
- 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 prior to study drug administration;
- Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
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- Consumption of alcohol within 72 hours prior to study drug administration;
- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
- 17.10. Current enrollment in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: A Phase 1, Open-Label, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects.
The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.
- Conditions
- Healthy
- Being tested
- omaveloxolone
- Keywords
- omaveloxolone, omaveloxolone capsules, RTA 408
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 50 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Food Effect (Fasted) | Experimental | Subjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fasted state (Period 1) with a crossover and then in the fed state (Period 2).
Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2. Receives: Drug: omaveloxolone |
| Effect (Fed) | Experimental | Subjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fed state (Period 1) with a crossover and then in the fasted state (Period 2).
Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2. Receives: Drug: omaveloxolone |
| Dose Proportionality | Experimental | Subjects will be randomly assigned to one of two omaveloxolone dosages. A single dose of omaveloxolone (in either 50 mg or 100 mg) will be administered to the subjects in 50 mg capsules in a fasted state.
Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 6. Receives: Drug: omaveloxolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax)
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Measured: 20 days
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC)
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under curve (AUC).
Measured: 20 days
Secondary outcomes (1)
Incidence of treatment-emergent adverse events
Safety will be assessed based on the number of treatment-emergent adverse events as defined by the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start29 Oct 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664453
- Sponsor's protocol ID
- 408-C-1703
- Status last verified
- May 2025
- First submitted
- 6 Sep 2018
- 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, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03664453
- Acronym / sponsor ID
- 408-C-1703
- Conditions
- Healthy
- Keywords
- omaveloxolone, omaveloxolone capsules, RTA 408
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 10 Sep 2018 (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 determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects.
The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food Effect (Fasted) | Experimental | Drug: omaveloxoloneSubjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fasted state (Period 1) with a crossover and then in the fed state (Period 2). Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2. |
| Effect (Fed) | Experimental | Drug: omaveloxoloneSubjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fed state (Period 1) with a crossover and then in the fasted state (Period 2). Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2. |
| Dose Proportionality | Experimental | Drug: omaveloxoloneSubjects will be randomly assigned to one of two omaveloxolone dosages. A single dose of omaveloxolone (in either 50 mg or 100 mg) will be administered to the subjects in 50 mg capsules in a fasted state. Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 6. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female and age is between 18 and 55 years, inclusive;
- All female subjects must have negative results for pregnancy tests performed;
- If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
- If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
- Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;
Key exclusion criteria (10 listed)
- 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;
- Recent (6-month) history of drug or alcohol abuse;
- 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 prior to study drug administration;
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 50 mg capsules | Drug | Dose Proportionality, Effect (Fed), Food Effect (Fasted) |
Primary outcome
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax)
Time frame: 20 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC)
Time frame: 20 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under curve (AUC).
1 secondary outcome
Incidence of treatment-emergent adverse events
Time frame: 6 days
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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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Healthy, 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 10 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?
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax) (time frame: 20 days). The study lists 2 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.