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Healthy VolunteersPhase 1NCT01598363

An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers

A Phase 1 study testing Digoxin and Rosuvastatin in people with Healthy Volunteers, run by Biogen at 1 site 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 evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin. 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?
Digoxin and Rosuvastatin
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
30 Jun 2012to 31 Jul 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female subjects between 18 and 45 years, inclusive;
  • Willing to practice a 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;
  • Body mass index (BMI) between 19 and 31 kg/m2, inclusive;
  • Willing and able to give written informed consent for study participation;
  • Willing and able to cooperate with all aspects of the protocol.

Who cannot join

  • Participated in another clinical trial of an investigational drug (or medical device) within 30 days before Study Day -1, or are currently participating in another trial of an investigational drug (or medical device);
  • 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);
  • Known hypersensitivity to any component in the formulation of bardoxolone methyl, LANOXIN®, or CRESTOR®;
  • 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 alcohol abuse or dependence within the last year;
  • Any vaccination within 30 days before start of this study and throughout the study;
  • Use of aspirin, non-steroidal anti-inflammatory agents, or acetaminophen within 5 days before Study Day 1; 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;
  • 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;
  • Donation or receipt of blood or blood components within the 4 weeks before 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;
  • Any diagnostic or intervention procedure requiring a contrast agent within the 30 days before study participation;
  • Systolic blood pressure > 140mmHg or < 100mmHg or a diastolic blood pressure >95 mmHg at screening measured after 5 minutes in a sitting position;
  • A pulse rate at rest in a sitting position of < 50 bpm or > 100 bpm;
  • Abnormal screening ECG (including a QTcF interval of >450 ms) which is interpreted by the investigator to be clinically significant, or any clinical evidence of Wolff-Parkinson-White syndrome, intermittent complete heart block, second degree heart block or prolonged PR interval of ≥ 200 msec on the 12-lead ECG;
  • Use of tobacco- or nicotine-containing products (that is, cigarettes, cigars, chewing tobacco, snuff, etc) or products for smoking cessation within 2 weeks before Study Day -1;
  • Consumed alcohol or xanthine-containing products (e.g., tea, coffee, chocolate, cola, etc.) within 72 hours before Study Day -1;
  • Treated with any investigational agent within 30 days before Study Day -1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer);
  • A history of drug abuse or who test positive for drug(s) of abuse (ethanol, amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids) or cotinine (indicating active current smoking) at the screening or Study Day -1;
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Spaulding Clinical Research, LLC

    West Bend, Wisconsin, 53095

Other trials in United States

About this study

The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin.

Read the detailed description

Subjects in Cohort 1 will receive a single dose of digoxin (0.5 mg) on Study Day 1, an initial dose of bardoxolone methyl (60 mg) and a single dose of digoxin (0.5 mg) on Study Day 10, and once daily doses of bardoxolone methyl (20 mg) on Study Days 11 through 14. Subjects in Cohort 2 will receive a single dose of rosuvastatin (20 mg) on Study Day 1, an initial dose of bardoxolone methyl (60 mg) and a single dose of rosuvastatin (20 mg) on Study Day 10, and once daily doses of bardoxolone methyl (20 mg) on Study Days 11 through 14. All doses will be given in the morning under fasting conditions. Bardoxolone methyl and the probe substrates (digoxin, rosuvastatin) will be dosed at the same time. Confinement will begin on Study Day -1 (Study Day before the first dosing day) and end after the collection of the 216 hour blood samples and scheduled study procedures on Study Day 19.

Being tested
Digoxin, Rosuvastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DigoxinDrug

    Oral, Day 1 and Day 10

  • RosuvastatinDrug

    Oral, Day 1 and Day 10

Study groups in NCT01598363
Study groupRoleWhat they receive
Digoxin 0.5mg, Bardoxolone Methyl 20mg and 60mgExperimentalNot described
Receives: Drug: Digoxin
Rosuvastatin 20mg, Bardoxolone Methyl 20mg and 60mgExperimentalNot described
Receives: Drug: Rosuvastatin

What is being measured

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

  1. Maximum observed concentration

    For Digoxin and Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

Secondary outcomes (10)

  1. Time to maximum observed concentration

    For Digoxin and Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

  2. Area under the plasma-concentration time-curve

    For Digoxin and Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

  3. Oral clearance

    For Digoxin and Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

  4. Terminal rate constant

    For Digoxin and Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

  5. Terminal half-life

    For Digoxin and Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

  6. Amount excreted in Urine

    For Digoxin only

    Measured: 0-24, 24-48, 484-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 hours post-dose

  7. Fraction of the dose excreted in Urine

    For Digoxin only

    Measured: 0-24, 24-48, 484-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 hours post-dose

  8. Renal clearance

    For Digoxin only

    Measured: 0-24, 24-48, 484-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 hours post-dose

  9. Number of patients with Adverse Events

    Measured: Approximately 1 year

  10. Determination of concentration for Bardoxolone Methyl

    Sample will be taken at 0 hours and 3 hours after dosing only on Study Days 10, 12 and 14

    Measured: 0 hours and 3 hours after dosing

Timeline

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

  1. First posted15 May 2012 (estimated)
  2. Study start30 Jun 2012
  3. Primary completion31 Jul 2012
  4. Study completion31 Jul 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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01598363
Sponsor's protocol ID
402-C-1104
Status last verified
May 2025
First submitted
11 May 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 Digoxin and Rosuvastatin 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 5 inclusion and 22 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?

Maximum observed concentration (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose). 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 NCT01598363.

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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