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Hepatic ImpairmentPhase 1NCT01563562

Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

A Phase 1 study testing Bardoxolone Methyl in people with Hepatic Impairment and Healthy, run by Biogen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment, 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
34 participants
Where
2 sitesUnited States
Study dates
30 Apr 2012to 30 Nov 2012
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects
  • Male or female subjects between 18 and 70 years, inclusive; must meet all of the following criteria to be included in the study:
  • Willing to practice method 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 before enrollment into the study;
  • Body mass index (BMI) between 18 and 37 kg/m2;
  • Willing and able to give written informed consent for study participation;
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  • Willing and able to cooperate with all aspects of the protocol.
  • Subjects with hepatic impairment
  • Have documented evidence of hepatic cirrhosis by biopsy, nuclear scan, CT, MRI, ultrasound, or other clinically acceptable methods; must meet all of the following criteria to be included in the study:
  • Be classified as Child-Pugh class A (mild), B (moderate), or C (severe). (See Appendix A for Child-Pugh system.)

Who cannot join

  • All subjects
  • Participated in another clinical trial of an investigational drug (or a medical device) within 30 days of Study Day -1, or are currently participating in another trial of an investigational drug (or a medical device); with any of the following conditions or characteristics must be excluded from the study:
  • Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
  • 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;
  • Donation or receipt of blood or blood components within the 4 weeks prior to Study Day -1. 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;
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  • Abnormal screening ECG which is interpreted by the investigator to be clinically significant;
  • A positive test for drug(s) of abuse (ethanol, amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids) at the screening or the Day -1 visit, unless the positive drug screen is for a subject with hepatic impairment for a prescription drug and is approved by the principal investigator;
  • 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;
  • Positive test results for human immunodeficiency virus type 1 or 2 antibody at screening;
  • Have an estimated creatinine clearance < 60 mL/min on Study Day -1 using the Cockcroft-Gault equation (Appendix B);
  • Any condition possibly affecting absorption, distribution, metabolism or excretion of drugs that may confound the analyses conducted in this study (for example: previous surgery on the gastrointestinal tract that includes removal of parts of stomach, bowel, liver, gall bladder, pancreas, venacaval shunts, or transjugular intrahepatic portosystemic shunts]).
  • Subjects with hepatic impairment
  • Sustained systolic blood pressure > 160 mmHg or < 100 mmHg or a diastolic blood pressure > 100 mmHg at screening or baseline measured after 5 minutes in a sitting position; who have any of the following conditions or characteristics must be excluded from the study:
  • A pulse rate at rest in a sitting position of < 45 bpm or > 105 bpm;
  • Documented evidence of primary biliary cirrhosis;
  • Evidence of recent (two months or less) or current gastrointestinal bleeding;
  • Platelet counts <50,000 or >450,000.
  • Subjects with normal hepatic function
  • Sustained systolic blood pressure > 150 mmHg or < 100 mmHg or a diastolic blood pressure > 95 mmHg at screening measured after 5 minutes in a sitting position; who have any of the following conditions or characteristics must be excluded from the study:
  • A pulse rate at rest in a sitting position of < 45 bpm or > 100 bpm;
  • 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 hepatitis B virus antibody, or hepatitis C virus antibody at screening;
  • Use of or need for any systemic drug(s) including vitamins or herbal preparations other than drugs used for contraception, within 10 days before Study Day -1 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University

    Durham, North Carolina, 27710

  • University of Miami School of Medicine

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to 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 groups in NCT01563562
Study groupRoleWhat they receive
Bardoxolone Methyl 20 mgExperimentalNot described
Receives: Drug: Bardoxolone Methyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the plasma concentration-time curve

    Measured: 0, 0.5,1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 264, 312, and 360 hours following dose administration

Secondary outcomes (4)

  1. Time to maximum observed concentration

    Measured: 0, 0.5,1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 264, 312, and 360 hours following dose administration

  2. Oral clearance

    Measured: 0, 0.5,1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 264, 312, and 360 hours following dose administration

  3. Terminal half-life

    Measured: 0, 0.5,1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 264, 312, and 360 hours following dose administration

  4. Terminal rate constant

    Measured: 0, 0.5,1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 264, 312, and 360 hours following dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2012 (estimated)
  2. Study start30 Apr 2012
  3. Primary completion30 Nov 2012
  4. Study completion30 Nov 2012

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563562
Sponsor's protocol ID
402-C-1002
Status last verified
May 2025
First submitted
23 Mar 2012
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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bardoxolone Methyl in people with Hepatic Impairment and Healthy, run by Biogen at 2 sites 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 10 inclusion and 28 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 2 sites 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 the plasma concentration-time curve (time frame: 0, 0.5,1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 264, 312, and 360 hours following dose administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563562.

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.

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