Healthy VolunteersPhase 1NCT03264079
Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults
A Phase 1 study testing Bardoxolone methyl capsules 10 mg and Itraconazole capsules 100 mg in people with Healthy Volunteers, run by Biogen at 1 site in United States.
Trial summary
This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects. This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bardoxolone methyl capsules 10 mg and Itraconazole capsules 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 13 Nov 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female and age is between 18 and 55 years, inclusive;
- 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 or abstain from sexual activity for the duration of the study;
- If male, subject must be surgically sterile or practicing an approved method of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
- If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
- Body Mass Index (BMI) is ≥ 18 to ≤31 kg/m2, inclusive;
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator;
- Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- History of clinically significant drug allergies, including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the investigator;
- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
- Known hypersensitivity to any component in the formulations of bardoxolone methyl, or SPORANOX®;
- Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis;
- Use of any medications (over-the-counter and/or prescription medication), vitamins, and/or herbal supplements, within the 30-day period prior to study drug administration or within 5 half-lives (if known), whichever is longer;
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- Recent (6-month) history of drug or alcohol abuse;
- B-type natriuretic peptide (BNP) level >200 pg/mL at screening;
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab) at screening;
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
- Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration;
- Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
- Consumption of alcohol within 72 hours prior to study drug administration;
- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
- Current enrollment in another clinical study;
- Screening laboratory analyses that show any of the following abnormal laboratory results:
- Alanine transaminase (ALT) or aspartate aminotransferase (AST) levels above the upper limit of normal (ULN);
- Clinically significant abnormal ECG; ECG with QTc using Fridericia's correction formula (QTcF) > 450 msec is exclusionary;
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive either bardoxolone methyl or itraconazole.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: An Open-Label Study of the Effect of a Strong CYP3A4 Inhibitor (Itraconazole) on the Pharmacokinetics of Bardoxolone Methyl in Healthy Volunteers
This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.
This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy volunteers.
Read more
Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration).
Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be administered under fed conditions on Study Days 15-17, and Study Days 19-27.
On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 9 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during Period 2.
- Conditions
- Healthy Volunteers
- Being tested
- Bardoxolone methyl capsules 10 mg, Itraconazole capsules 100 mg
- Keywords
- RTA 402, Bardoxolone methyl, Itraconazole, Sporanox, CYP3A4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methyl capsules 10 mgDrug
Also called RTA 402
One 10 mg capsule of bardoxolone methyl administered on Study Day 1 (Period 1) of the trial and one 10 mg capsule of bardoxolone methyl administered on Study Day 18 (Period 2) of the trial
Itraconazole capsules 100 mgDrug
Also called Sporanox
Two 100 mg capsules of itraconazole administered once daily during Study Days 15 - 27 (Period 2) of the trial
| Study group | Role | What they receive |
|---|---|---|
| Bardoxolone methyl 10 mg and Itraconazole 200 mg | Experimental | Period 1: Bardoxolone methyl capsules 10 mg Period 2: two Itraconazole capsules 100 mg Receives: Drug: Bardoxolone methyl capsules 10 mg; Drug: Itraconazole capsules 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve of bardoxolone methyl from time 0 to the last measurable time point (AUC0-t).
Measured: 28 days
Area under the plasma concentration-time curve of bardoxolone methyl extrapolated to infinity (AUC0-inf)
Measured: 28 days
Maximum observed drug concentration (Cmax) in plasma of 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 posted28 Aug 2017
- Study start16 Oct 2017
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants are placed into a one group to receive two interventions: one intervention during Period 1 and a second intervention during Period 2. For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration)
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264079
- Sponsor's protocol ID
- 402-C-1701
- Status last verified
- May 2025
- First submitted
- 23 Aug 2017
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
- An Open-Label Study of the Effect of a Strong CYP3A4 Inhibitor (Itraconazole) on the Pharmacokinetics of Bardoxolone Methyl in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03264079
- Acronym / sponsor ID
- 402-C-1701
- Conditions
- Healthy Volunteers
- Keywords
- RTA 402, Bardoxolone methyl, Itraconazole, Sporanox, CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 28 Aug 2017 (actual)
- 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 trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.
This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy volunteers.
Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration).
Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be administered under fed conditions on Study Days 15-17, and Study Days 19-27.
On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 9 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are placed into a one group to receive two interventions: one intervention during Period 1 and a second intervention during Period 2. For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration)
| Arm | Type | Receives |
|---|---|---|
| Bardoxolone methyl 10 mg and Itraconazole 200 mg | Experimental | Drug: Bardoxolone methyl capsules 10 mg, Drug: Itraconazole capsules 100 mgPeriod 1: Bardoxolone methyl capsules 10 mg Period 2: two Itraconazole capsules 100 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female and age is between 18 and 55 years, inclusive;
- 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 or abstain from sexual activity for the duration of the study;
- If male, subject must be surgically sterile or practicing an approved method of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
- If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
- Body Mass Index (BMI) is ≥ 18 to ≤31 kg/m2, inclusive;
Key exclusion criteria (20 listed)
- History of clinically significant drug allergies, including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the investigator;
- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
- Known hypersensitivity to any component in the formulations of bardoxolone methyl, or SPORANOX®;
- Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis;
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 capsules 10 mgAlso: RTA 402One 10 mg capsule of bardoxolone methyl administered on Study Day 1 (Period 1) of the trial and one 10 mg capsule of bardoxolone methyl administered on Study Day 18 (Period 2) of the trial | Drug | Bardoxolone methyl 10 mg and Itraconazole 200 mg |
| Itraconazole capsules 100 mgAlso: SporanoxTwo 100 mg capsules of itraconazole administered once daily during Study Days 15 - 27 (Period 2) of the trial | Drug | Bardoxolone methyl 10 mg and Itraconazole 200 mg |
Primary outcome
Area under the plasma concentration-time curve of bardoxolone methyl from time 0 to the last measurable time point (AUC0-t).
Time frame: 28 days
Area under the plasma concentration-time curve of bardoxolone methyl extrapolated to infinity (AUC0-inf)
Time frame: 28 days
Maximum observed drug concentration (Cmax) in plasma of 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 capsules 10 mg and Itraconazole capsules 100 mg 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 7 inclusion and 20 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 the plasma concentration-time curve of bardoxolone methyl from time 0 to the last measurable time point (AUC0-t). (time frame: 28 days). The study lists 3 primary outcomes in all. 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.