Healthy VolunteersPhase 1NCT01689116
Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
A Phase 1 study testing Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg and Moxifloxacin 400mg in people with Healthy Volunteers, run by Biogen at 1 site in United States.
Trial summary
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg and Moxifloxacin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects must meet all of the following criteria to be included in the study:
- Healthy male and female subjects between 18 to 50 years of age, inclusive. Healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at screening;
- BMI greater than or equal to 18 kg/m2 but not to exceed 32 kg/m2;
- Female subjects of childbearing potential must not be planning a pregnancy, pregnant, or lactating, and must have a negative serum pregnancy test result before enrollment into the study, and must be willing to use contraception as specified in section 12.8.3 or abstain from sexual activity for the duration of the study and for at least 3 weeks after discontinuation of study drug;
- Male subjects and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 30 days after completion;
- Agree to abstain from alcohol consumption up to 3 days before dosing and throughout duration of the study (including the Study Day 13 visit);
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- Agree to abstain from strenuous exercise from 3 days before dosing and throughout duration of the study (including the Study Day 13 visit);
- Able to effectively communicate with the investigator and other testing center personnel;
- Able to participate, and willing to give written informed consent and to comply with the study restrictions.
Who cannot join
- All subjects with any of the following conditions or characteristics must be excluded from the study:
- Currently participating in another study of an investigational drug (or a medical device) or have participated in another clinical study of an investigational drug (or a medical device) within 30 days of Study Day -1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer);
- 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;
- History of smoking or tobacco use within the 6 months prior to Study Day -1;
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- 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;
- History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or Torsades de Pointes, structural heart disease, or family history of long QT syndrome (suggested by sudden death due to cardiac causes at a young age of a close relative);
- Evidence of any of the following cardiac conduction abnormalities based on the safety ECG at Screening:
- Fridericia's correction for QT (QTcF) interval > 450 ms for males, > 470 ms for females;
- PR interval < 110 ms or > 240 ms;
- Intraventricular conduction delay with QRS duration >120 ms;
- Resting heart rate < 40 bpm or > 90 bpm;
- Pathological Q-waves (defined as Q-wave > 40 ms or depth > 0.4-0.5 mV);
- Second- or third-degree atrioventricular block (AVB);
- Electrocardiographic evidence of complete left bundle branch block (LBBB), right bundle branch block (RBBB), or incomplete left bundle branch block (LBBB);
- Ventricular pre-excitation;
- Atrial fibrillation, atrial flutter, or artificial cardiac pacemaker;
- Screening ECG renders measurement of QT interval in lead II imprecise (for example: flat T waves, arrhythmias);
- Subjects who have a screening supine blood pressure (BP) outside 90-145 mm Hg systolic or 45-95 mm Hg diastolic (measured following at least a 10-minute rest). Blood pressure may be re-tested twice in the supine 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 and the subject may not be randomized;
- Use of any concomitant medications that are known to prolong QT/QTc interval within 30 days prior to Study Day -1;
- Allergy to moxifloxacin or any fluoroquinolone antibiotic;
- A positive test for drug(s) of abuse (alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids) at the screening or the Day -2 visit;
- 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;
- 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, venocaval shunts, or transjugular intrahepatic portosystemic shunts]);
- 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 transferase (GGT), lactate dehydrogenase (LDH), or alkaline phosphatase levels to greater than the upper limit of normal (ULN) at screening;
- Abnormal hematological and biochemical parameters, including neutrophil count < 1500 cells/mm3, Hgb < 11 g/dL in females or < 12 g/dL in males, platelet count < 90,000 cells/mm3, creatinine ≥ 1.5 X ULN, albumin ≤ 3 g/dL, serum amylase or lipase ≥ 1.5X ULN at screening;
- Positive test results for hepatitis B virus antibody, or hepatitis C virus antibody at screening;
- Use of or need for any prescription or non-prescription systemic drug(s) including vitamins or herbal preparations other than drugs used for contraception, aspirin, acetaminophen, or other non-steroidal anti-inflammatory agents, 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 Study Day -1;
- Consumption of alcohol- or caffeine-containing compounds within 24 hours before Day -2 visit;
- Consumption of citrus juice within the 7 days before Day -2 visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53012
About this study
Official title: A Blinded Randomized Parallel Trial to Define the ECG Effects of Bardoxolone Methyl Using a Clinical and a Supratherapeutic Dose Compared to Placebo and Moxifloxacin (a Positive Control) in Healthy Men and Women: A Thorough ECG Trial.
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg, Bardoxolone Methyl Placebo, Moxifloxacin 400mg, Moxifloxacin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone Methyl 20mgDrug
Oral
Bardoxolone Methyl 80mgDrug
Oral
Bardoxolone Methyl PlaceboDrug
Oral
Moxifloxacin 400mgDrug
Oral
Moxifloxacin PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Bardoxolone Methyl 20mg | Experimental | Not described Receives: Drug: Bardoxolone Methyl 20mg; Drug: Bardoxolone Methyl Placebo; Drug: Moxifloxacin Placebo |
| Bardoxolone Methyl 80mg | Experimental | Not described Receives: Drug: Bardoxolone Methyl 80mg; Drug: Moxifloxacin Placebo |
| Bardoxolone Methyl Placebo | Placebo comparator | Not described Receives: Drug: Bardoxolone Methyl Placebo; Drug: Moxifloxacin Placebo |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Bardoxolone Methyl Placebo; Drug: Moxifloxacin 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT/QTc interval
Measured: Baseline, Day 6 and Day 13
Secondary outcomes (7)
Maximum observed concentration
0 (immediately before dose administrations), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours following dose
Measured: Day 1 and Day 6
Time to maximum observed concentration
0 (immediately before dose administrations), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours following dose
Measured: Day 1 and Day 6
Area under the plasma concentration-time curve from time 0 to last observed concentration
0 (immediately before dose administrations), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours following dose
Measured: Day 1 and Day 6
Area under curve for the dosing interval
0 (immediately before dose administrations), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours following dose
Measured: Day 1 and Day 6
Accumulation index for maximum observed concentration
0 (immediately before dose administrations), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours following dose
Measured: Day 1 and day 6
Accumulation index for area under the curve from time 0 to 24 hours
0 (immediately before dose administrations), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours following dose
Measured: Day 1 and Day 6
Number of Adverse Events
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study start31 Aug 2012
- Primary completion30 Nov 2012
- Study completion30 Nov 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689116
- Sponsor's protocol ID
- 402-C-1006
- Status last verified
- May 2025
- First submitted
- 14 Sep 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
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 Blinded Randomized Parallel Trial to Define the ECG Effects of Bardoxolone Methyl Using a Clinical and a Supratherapeutic Dose Compared to Placebo and Moxifloxacin (a Positive Control) in Healthy Men and Women: A Thorough ECG Trial.
- ClinicalTrials.gov ID
- NCT01689116
- Acronym / sponsor ID
- 402-C-1006
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2012 (actual)
- Primary completion
- 30 Nov 2012 (actual)
- Study completion
- 30 Nov 2012 (actual)
- First posted
- 21 Sep 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.
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bardoxolone Methyl 20mg | Experimental | Drug: Bardoxolone Methyl 20mg, Drug: Bardoxolone Methyl Placebo, Drug: Moxifloxacin Placebo |
| Bardoxolone Methyl 80mg | Experimental | Drug: Bardoxolone Methyl 80mg, Drug: Moxifloxacin Placebo |
| Bardoxolone Methyl Placebo | Placebo comparator | Drug: Bardoxolone Methyl Placebo, Drug: Moxifloxacin Placebo |
| Moxifloxacin | Active comparator | Drug: Bardoxolone Methyl Placebo, Drug: Moxifloxacin 400mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female subjects between 18 to 50 years of age, inclusive. Healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at screening;
- BMI greater than or equal to 18 kg/m2 but not to exceed 32 kg/m2;
- Female subjects of childbearing potential must not be planning a pregnancy, pregnant, or lactating, and must have a negative serum pregnancy test result before enrollment into the study, and must be willing to use contraception as specified in section 12.8.3 or abstain from sexual activity for the duration of the study and for at least 3 weeks after discontinuation of study drug;
- Male subjects and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 30 days after completion;
- Agree to abstain from alcohol consumption up to 3 days before dosing and throughout duration of the study (including the Study Day 13 visit);
Key exclusion criteria (34 listed)
- All subjects with any of the following conditions or characteristics must be excluded from the study:
- Currently participating in another study of an investigational drug (or a medical device) or have participated in another clinical study of an investigational drug (or a medical device) within 30 days of Study Day -1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer);
- 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;
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 Methyl 20mgOral | Drug | Bardoxolone Methyl 20mg |
| Bardoxolone Methyl 80mgOral | Drug | Bardoxolone Methyl 80mg |
| Bardoxolone Methyl PlaceboOral | Drug | Bardoxolone Methyl 20mg, Bardoxolone Methyl Placebo, Moxifloxacin |
| Moxifloxacin 400mgOral | Drug | Moxifloxacin |
| Moxifloxacin PlaceboOral | Drug | Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg, Bardoxolone Methyl Placebo |
Primary outcome
Change in QT/QTc interval
Time frame: Baseline, Day 6 and Day 13
7 secondary outcomes
Maximum observed concentration
Time frame: Day 1 and Day 6
Time to maximum observed concentration
Time frame: Day 1 and Day 6
Area under the plasma concentration-time curve from time 0 to last observed concentration
Time frame: Day 1 and Day 6
Area under curve for the dosing interval
Time frame: Day 1 and Day 6
Accumulation index for maximum observed concentration
Time frame: Day 1 and day 6
Accumulation index for area under the curve from time 0 to 24 hours
Time frame: Day 1 and Day 6
Number of Adverse Events
Time frame: Approximately 6 months
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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Screening Protocol
Pain
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 20mg, Bardoxolone Methyl 80mg and Moxifloxacin 400mg 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 9 inclusion and 34 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. Some participants in this study may receive a placebo. 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?
Change in QT/QTc interval (time frame: Baseline, Day 6 and Day 13). 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.