HealthyPhase 1NCT01503866
A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects
A Phase 1 study testing bardoxolone methyl in people with Healthy, run by Biogen at 1 site in United States.
Trial summary
The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, between ages 18 and 45 years, inclusive;
- Males will either be sterile or agree to use from Check-in (Day -1) until 45 days following Clinic Discharge, i of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (eg, NuvaRing); a diaphragm with spermicide;a cervical cap with spermicide; oral, implantable, transdermal, or injectable contraceptives;
- Within a BMI range 19 to 31 kg/m2, inclusive;
- 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;
- at least 1 regular bowel movement per day.
Who cannot join
- Participated in another clinical trial of an investigational drug (or a medical device) within 30 days prior to study entry, or are currently participating in another trial of an investigational drug (or a medical device);
- Participated in a [14C]-study within the last 6 months prior to Check-in (Day -1) for this study. The total exposure from this and any previous study must be within the recommended levels considered safe (per 21 Code of Federal Regulations [CFR] 361.1 2010), for example, less than 5,000 mrem/year whole body exposure;
- Exposure to significant radiation within 12 months prior to Check-in (Day -1);
- Any condition possibly affecting absorption, distribution, metabolism, or excretion of drugs that may confound the analyses conducted in this study;
- Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
- Evidence or history of or concurrent clinically significant allergic, 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;
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- Evidence of hepatic or biliary dysfunction including elevation of total bilirubin, direct bilirubin, AST, ALT, GGT, lactate dehydrogenase, or alkaline phosphatase levels to greater than the upper limit of normal;
- Positive test results for human immunodeficiency virus type 1 or 2 antibody, hepatitis B surface antigen, or hepatitis C virus antibody at Screening;
- 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 prior to Day 1 and throughout the study;
- Use of or need for any systemic drug(s) including vitamins or herbal preparations within 30 days prior to Day 1 or during the study;
- Use of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or acetaminophen within 5 days prior to the ingestion of the study drug; use of aspirin or NSAIDs (but not acetaminophen) will be allowed during confinement for isolated episodes of pain at the discretion of the Investigator;
- Donation or receipt of blood or blood components within 4 weeks prior to Screening;
- Any diagnostic or intervention procedure requiring a contrast agent within the 30 days prior to Screening;
- 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;
- A pulse rate at rest in a sitting position of < 45 bpm or > 100 bpm;
- An abnormal Screening ECG which is interpreted by the Investigator to be clinically significant;
- Used tobacco- or nicotine-containing products (eg, cigarettes, cigars, chewing tobacco, snuff) or products for smoking cessation 2 weeks prior to study drug administration or during confinement to the Clinical Research Unit (CRU);
- Treated with any investigational agent within 30 days before Check-in (Day -1) or 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer);
- A positive history of drug abuse or positive results for screening test for drug(s) of abuse, ethanol, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, cannabinoids, or urine cotinine (indicating active current smoking) at the Screening or Check-in (Day -1) visits;
- Poor peripheral venous access;
- Deemed by the Investigator to be inappropriate for this study;
- 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's outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Bardoxolone Methyl Following a Single Oral Dose Administration in Healthy Male Subjects
The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl.
- Conditions
- Healthy
- 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under curve
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
Secondary outcomes (6)
radioactivity in plasma
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
metabolites of ]14C]-bardoxolone methyl
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
Plasma concentrations of cold bardoxolone methyl
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
radioactivity in urine
Measured: 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120,120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240, 240 to 264, 264 to 288, and 288 to 312 hours after dose administration
radioactivity in feces
Measured: 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120,120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240, 240 to 264, 264 to 288, and 288 to 312 hours after dose administration
radioactivity in whole blood
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study start1 Dec 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 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine L Hale, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503866
- Sponsor's protocol ID
- 402-C-1003
- Status last verified
- May 2025
- First submitted
- 22 Dec 2011
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- 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 Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Bardoxolone Methyl Following a Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01503866
- Acronym / sponsor ID
- 402-C-1003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 4 Jan 2012 (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.
The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 mg bardoxolone methyl | Experimental | Drug: bardoxolone methyl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males, between ages 18 and 45 years, inclusive;
- Males will either be sterile or agree to use from Check-in (Day -1) until 45 days following Clinic Discharge, i of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (eg, NuvaRing); a diaphragm with spermicide;a cervical cap with spermicide; oral, implantable, transdermal, or injectable contraceptives;
- Within a BMI range 19 to 31 kg/m2, inclusive;
- 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;
Key exclusion criteria (24 listed)
- Participated in another clinical trial of an investigational drug (or a medical device) within 30 days prior to study entry, or are currently participating in another trial of an investigational drug (or a medical device);
- Participated in a [14C]-study within the last 6 months prior to Check-in (Day -1) for this study. The total exposure from this and any previous study must be within the recommended levels considered safe (per 21 Code of Federal Regulations [CFR] 361.1 2010), for example, less than 5,000 mrem/year whole body exposure;
- Exposure to significant radiation within 12 months prior to Check-in (Day -1);
- Any condition possibly affecting absorption, distribution, metabolism, or excretion of drugs that may confound the analyses conducted in this study;
- Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
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 |
Primary outcome
area under curve
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
6 secondary outcomes
radioactivity in plasma
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
metabolites of ]14C]-bardoxolone methyl
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
Plasma concentrations of cold bardoxolone methyl
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
radioactivity in urine
Time frame: 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120,120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240, 240 to 264, 264 to 288, and 288 to 312 hours after dose administration
radioactivity in feces
Time frame: 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120,120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240, 240 to 264, 264 to 288, and 288 to 312 hours after dose administration
radioactivity in whole blood
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
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.
Christine L Hale, MD principal investigator
Covance Clinical Research Unit
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, 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 24 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?
area under curve (time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration). 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.