Healthy Male SubjectsPhase 1NCT03931590
A Human AME Study for Omaveloxolone
A Phase 1 study testing [14C]-Omaveloxolone in people with Healthy Male Subjects, run by Biogen at 1 site in United States.
Trial summary
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- [14C]-Omaveloxolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 31 May 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
- Men only
- 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, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and a total body weight > 50 kg.
- Be surgically sterile or willing to agree to use contraception
- In good health, as assessed by the investigator (or designee).
- 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).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- Abnormal laboratory values considered clinically significant by the investigator.
- Clinically significant abnormal 12-lead ECGs.
Show all 12Show fewer
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day-1).
- Alcohol consumption of > 21 units per week.
- Positive urine drug screen at Screening, or positive alcohol breath test result or positive urine drug screen at Check-in (Day -1).
- 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 or 5 half-lives (if known) prior to dosing.
- Current enrollment in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit (CRU) Inc.
Madison, Wisconsin, 53704
About this study
Official title: Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.
- Conditions
- Healthy Male Subjects
- Being tested
- [14C]-Omaveloxolone
- Keywords
- RTA 408, RTA 408 capsules, omaveloxolone, omaveloxolone capsules, AME, mass balance, metabolite identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-OmaveloxoloneDrug
Also called [14C]-RTA 408
[14C]-Omaveloxolone 50 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Healthy Male Subjects | Experimental | Single oral dose of 150 mg of [14C] omaveloxolone containing approximately 90 μCi as a capsule after an overnight fast of at least 10 hours. Receives: Drug: [14C]-Omaveloxolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Measured: 22 days
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: 22 days
Maximum concentration of total radioactivity in blood and plasma
Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity
Measured: 22 days
Area under the concentration-time curve total radioactivity in blood and plasma
Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.
Measured: 22 days
Amount of radioactivity excreted in urine (Aeu)
Rates and routes of elimination will be assessed by urine sampling for radioactivity.
Measured: 22 days
Amount of radioactivity excreted in feces (Aef)
Rates and routes of elimination will be assessed by sampling of feces for radioactivity.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start11 Apr 2019
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Siebers, MD, Principal investigator, Covance CRU Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931590
- Sponsor's protocol ID
- 408-C-1805
- Status last verified
- May 2025
- First submitted
- 25 Apr 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
- Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03931590
- Acronym / sponsor ID
- 408-C-1805
- Conditions
- Healthy Male Subjects
- Keywords
- RTA 408, RTA 408 capsules, omaveloxolone, omaveloxolone capsules, AME, mass balance, metabolite identification
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 30 Apr 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 pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Male Subjects | Experimental | Drug: [14C]-OmaveloxoloneSingle oral dose of 150 mg of [14C] omaveloxolone containing approximately 90 μCi as a capsule after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- 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, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and a total body weight > 50 kg.
- Be surgically sterile or willing to agree to use contraception
- In good health, as assessed by the investigator (or designee).
Key exclusion criteria (12 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).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- Abnormal laboratory values considered clinically significant by the investigator.
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 |
|---|---|---|
| [14C]-OmaveloxoloneAlso: [14C]-RTA 408[14C]-Omaveloxolone 50 mg capsules | Drug | Healthy Male Subjects |
Primary outcome
Maximum concentration (Cmax) of omaveloxolone
Time frame: 22 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Area under the omaveloxolone concentration-time curve (AUC)
Time frame: 22 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Maximum concentration of total radioactivity in blood and plasma
Time frame: 22 days
Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity
Area under the concentration-time curve total radioactivity in blood and plasma
Time frame: 22 days
Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.
Amount of radioactivity excreted in urine (Aeu)
Time frame: 22 days
Rates and routes of elimination will be assessed by urine sampling for radioactivity.
Amount of radioactivity excreted in feces (Aef)
Time frame: 22 days
Rates and routes of elimination will be assessed by sampling of feces for radioactivity.
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.
Nicholas Siebers, 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 [14C]-Omaveloxolone in people with Healthy Male 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 12 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: 22 days). The study lists 6 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.