Healthy VolunteersPhase 1NCT01461161
A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
A Phase 1 study testing bardoxolone methyl in people with Healthy Volunteers, run by Biogen at 1 site in United States.
Trial summary
This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- bardoxolone methyl
- 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
- 31 Oct 2011to 31 Dec 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or Females between 18 and 45 years of age;
- Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested;
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;
- Body mass index (BMI) between 19 and 31 kg/m2;
- Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records that describe events captured in the endpoints;
- Willing and able to cooperate with all aspects of the protocol.
Who cannot join
- Participated in another clinical trial of an investigational drug (or a medical device) within the last 30 days, or are currently participating in another trial of an investigational drug (or a medical device);
- Any condition possibly affecting absorption, distribution, metabolism or excretion of drugs that may confound the analyses conducted in this study [e.g., previous surgery on the gastrointestinal tract that includes removal of parts of stomach, bowel, liver, gall bladder, or pancreas];
- Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
- Evidence or history of or concurrent clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dose administration), hematological, endocrine, immunological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease that in the judgment of the investigator could potentially either pose a health risk to the subject during the study or influence the study outcome;
- Evidence of hepatic or biliary dysfunction including elevation of total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), or alkaline phosphatase levels to greater than the upper limit of normal (ULN);
- Positive test results for human immunodeficiency virus type 1 or 2 antibody, hepatitis B surface antigen, or hepatitis C virus antibody at screening;
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- Any medical or dental procedure, no matter how minor, that is planned or anticipated to occur during the conduct of the study;
- History of drug or alcohol abuse or dependence within the last year;
- Any vaccination within 30 days before start of this study and throughout the study;
- Use of or need for any systemic drug(s) including vitamins or herbal preparations other than drugs used for contraception, within 30 days before entry into the study or during the study;
- Use of aspirin, non-steroidal anti-inflammatory agents, or acetaminophen within 5 days prior to the ingestion of the study drug; use of aspirin or non-steroidal anti inflammatory agents (but not acetaminophen) will be allowed for isolated episodes of pain at the discretion of the investigator;
- Donation or receipt of blood or blood components within the 4 weeks prior to the study. The investigator should instruct subjects who participate in this study not to donate blood or blood components for 4 weeks after the completion of the study;
- Any diagnostic or intervention procedure requiring a contrast agent within the 30 days prior to study participation;
- Sustained systolic blood pressure > 140 mmHg or < 100 mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline measured after 5 minutes in a sitting position. Blood pressure may be re-tested twice in a sitting position at intervals of 5 minutes. The pressure elevation is considered sustained if either the systolic or the diastolic pressure exceeds the stated limits after three assessments;
- A pulse rate at rest of < 45 bpm or > 100 bpm;
- Abnormal screening ECG which is interpreted by the investigator to be clinically significant;
- Used tobacco-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) or products for smoking cessation 2 weeks prior to Day -1 of Period 1 of the study;
- Consumed alcohol or xanthine-containing products (e.g., tea, coffee, chocolate, cola, etc.) within 72 hours prior to Day -1 of Period 1 of the study;
- Treated within 30 days before Day -1 of Period 1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer) with any investigational agent;
- A positive history of drug abuse or who test positive for drug(s) of abuse, ethanol, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, cannabinoids or cotinine (indicating active current smoking) at the screening or Day -1 of Period 1 visit;
- Female subjects who are planning a pregnancy or are pregnant or lactating;
- Deemed by the investigator to be inappropriate for this study, including subjects who are unable to communicate with the investigator due to language problems, poor mental development, or impaired cerebral function;
- Any concurrent clinical conditions that in the judgment of the investigator could either potentially pose a health risk to the subject while involved in the study or could potentially influence the study outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
- Conditions
- Healthy Volunteers
- Being tested
- bardoxolone methyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bardoxolone methylDrug
oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| 20 mg bardoxolone methyl | Experimental | Not described Receives: Drug: bardoxolone methyl |
| 60 mg bardoxolone methyl | Experimental | Not described Receives: Drug: bardoxolone methyl |
| 80 mg bardoxolone methyl | Experimental | Not described Receives: Drug: bardoxolone methyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of food on Pharmacokinetics of a 20 mg single dose of bardoxolone methyl
Measured: 28 Days
Secondary outcomes (1)
Dose proportionality of 20mg, 60mg, and 80mg bardoxolone methyl
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 posted27 Oct 2011 (estimated)
- Study start31 Oct 2011
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT01461161
- Sponsor's protocol ID
- 402-C-1004
- Status last verified
- May 2025
- First submitted
- 25 Oct 2011
- Last updated
- 29 May 2025
- Results posted
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
- ClinicalTrials.gov ID
- NCT01461161
- Acronym / sponsor ID
- 402-C-1004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2011 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 27 Oct 2011 (estimated)
- 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 is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mg bardoxolone methyl | Experimental | Drug: bardoxolone methyl |
| 60 mg bardoxolone methyl | Experimental | Drug: bardoxolone methyl |
| 80 mg bardoxolone methyl | Experimental | Drug: bardoxolone methyl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or Females between 18 and 45 years of age;
- Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested;
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;
- Body mass index (BMI) between 19 and 31 kg/m2;
- Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records that describe events captured in the endpoints;
Key exclusion criteria (23 listed)
- Participated in another clinical trial of an investigational drug (or a medical device) within the last 30 days, or are currently participating in another trial of an investigational drug (or a medical device);
- Any condition possibly affecting absorption, distribution, metabolism or excretion of drugs that may confound the analyses conducted in this study [e.g., previous surgery on the gastrointestinal tract that includes removal of parts of stomach, bowel, liver, gall bladder, or pancreas];
- Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
- Evidence or history of or concurrent clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dose administration), hematological, endocrine, immunological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease that in the judgment of the investigator could potentially either pose a health risk to the subject during the study or influence the study outcome;
- Evidence of hepatic or biliary dysfunction including elevation of total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), or alkaline phosphatase levels to greater than the upper limit of normal (ULN);
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 |
|---|---|---|
| bardoxolone methyloral, single dose | Drug | 20 mg bardoxolone methyl, 60 mg bardoxolone methyl, 80 mg bardoxolone methyl |
Primary outcome
Effect of food on Pharmacokinetics of a 20 mg single dose of bardoxolone methyl
Time frame: 28 Days
1 secondary outcome
Dose proportionality of 20mg, 60mg, and 80mg bardoxolone methyl
Time frame: 28 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 29 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 bardoxolone methyl in people with Healthy Volunteers, 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 23 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 29 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?
Effect of food on Pharmacokinetics of a 20 mg single dose of bardoxolone methyl (time frame: 28 Days). 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 29 May 2025.