Hepatic ImpairmentPhase 1NCT03902002
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing Omaveloxolone 50 mg capsules in people with Hepatic Impairment, run by Biogen at 3 sites in United States.
Trial summary
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function. 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
- What is being tested?
- Omaveloxolone 50 mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2019to 27 Jan 2020
- 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
- Males or females, of any race, between 18 and 70 years of age, inclusive.
- BMI between 18.0 and 38.0 kg/m2, inclusive, and body weight ≥ 50 kg.
- Females will not be pregnant (or planning to get pregnant) or lactating at Screening or Check in (Day 1), and females of childbearing potential and males will agree to use contraception .
- Male subjects must not donate sperm and female subjects must not donate ova from Check in (Day 1) until 90 days after their dose of study drug.
- Subjects with Normal Hepatic Function Only
- Matched to subjects with mild, moderate, or severe hepatic impairment in sex, age (± 10 years), and BMI (± 20%).
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- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non hemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check in as assessed by the investigator (or designee).
- Subjects with Hepatic Impairment Only
- Documented chronic stable liver disease (Child Pugh Class A [mild], B [moderate], or C [severe] at Screening); diagnosis of cirrhosis due to parenchymal liver disease. This will exclude biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder:
- 'Documented' is defined by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy.
- 'Chronic stable' is defined as no clinically significant change in disease status within the last 30 days, as documented by the subject's recent medical history (e.g., no worsening of clinical signs of hepatic impairment, or no worsening of total bilirubin or prothrombin time [PT] by more than 50%).
- Subjects with mild, moderate, or severe hepatic impairment may have medical findings consistent with their hepatic dysfunction, as determined by medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and Check in (Day 1). Subjects with abnormal findings considered not clinically significant by the investigator will be eligible.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- Ventricular dysfunction or history of risk factors for Torsade de Pointes (TdP; e.g., unexplained syncope, known long QT syndrome, heart failure, and cardiomyopathy). Subjects will be excluded if there is a family history of long QT syndrome.
- Evidence of hepatorenal syndrome and estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m2 or abnormal sodium and potassium levels, as determined by the investigator (or designee), calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at Screening or Check in (Day 1).
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- Clinically significant physical examination abnormality, as determined by the investigator (or designee).
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
- Use of any sensitive substrates for cytochrome P450 (CYP)2C8, moderate or strong inhibitors or inducers of CYP3A4/5, or substrates for p glycoprotein (P gp) within 30 days prior to study drug administration.
- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within 72 hours prior to study drug administration (Day 1) and throughout the study (until after the Follow up Visit).
- History of alcoholism or drug/chemical abuse within 6 months prior to Check in (Day 1).
- Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine within the 6 months prior to Check in (Day 1).
- Positive urine drug screen or positive alcohol breath or urine test result at Screening and Check in (Day 1), that is not otherwise explained by permitted concomitant medications. A positive alcohol test may be repeated once at Screening. A positive alcohol test may not be repeated at Check in (Day 1).
- Positive human immunodeficiency virus test (Appendix 2).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 10 half lives (if known), whichever is longer, prior to dosing.
- Current enrollment in another clinical study.
- Receipt of blood products within 2 months prior to Check in.
- Donation or loss of ≥ 550 mL blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Subjects with Normal Hepatic Function Only
- Confirmed supine blood pressure > 140 mmHg or < 90 mmHg and/or supine diastolic blood pressure > 90 mmHg or < 50 mmHg, or resting (supine) heart rate < 45 beats per minute (bpm) or > 100 bpm at Screening or Check in (Day 1), with a QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 ms for male subjects and > 470 ms for female subjects.
- Positive hepatitis panel (Appendix 2).
- Use of tobacco or nicotine containing products within 6 months prior to Check in (Day 1), or positive cotinine at Screening or Check in (Day 1).
- Clinically significant abnormal laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), as determined by the investigator (or designee).
- Significant history or clinical manifestation of hepatic disorder, as determined by the investigator (or designee).
- History or presence of liver disease or liver injury as indicated by any clinically significant deviations from normal reference ranges in liver function tests, unless approved by the investigator (or designee).
- History of diabetes mellitus.
- Use or intend to use any prescription medications/products other than prescribed hormone replacement therapy, implantable, or intrauterine contraceptives within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
- Use or intend to use slow release medications/products considered to still be active within 30 days prior to Check in (Day 1), unless deemed acceptable by the investigator (or designee).
- Use or intend to use any non prescription medications/products including vitamins, minerals, and phytotherapeutic , herbal , or plant derived preparations within 7 days prior to Check in (Day 1), unless deemed acceptable by the investigator (or designee).
- Subjects with Hepatic Impairment Only
- Confirmed supine blood pressure > 150 mmHg or < 90 mmHg and/or supine diastolic blood pressure > 90 mmHg or < 50 mmHg, or resting (supine) heart rate < 45 bpm or > 100 bpm at Screening or Check in (Day 1), with a QTcF > 470 ms for both male and female subjects.
- History of clinically significant left sided heart disease and/or clinically significant cardiac disease.
- Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the investigator (or designee).
- Use of a new medication, or a change in dose, for the treatment of hepatic encephalopathy within 90 days prior to Check in (Day 1).
- Use of prescription drugs within 30 days prior to Check in (Day 1), with the exception of therapies for hepatic disease and treatment of associated disorders that had been stable for at least 3 months prior to administration of study drug (Day 1) or prescribed hormone replacement therapy, implantable, or intrauterine contraceptives.
- Recent history of, or the treatment of, esophageal bleeding (within the past 180 days), unless banded.
- History of unstable diabetes mellitus (as evidenced by hemoglobin A1c [HbA1c] ≥ 9.0% at Screening). Concomitant medications for the treatment of diabetes mellitus must be approved by the investigator (or designee), Sponsor, and Covance Medical Monitor.
- Presence of a portosystemic shunt.
- Recent history of paracentesis within 90 days prior to Check in (Day 1).
- Current functioning organ transplant or awaiting an organ transplant.
- Evidence of severe ascites.
- Recent history of hepatic encephalopathy (Grade 2 or above) within 180 days prior to Screening.
- Smoke more than 10 cigarettes or use the equivalent tobacco or nicotine containing products per day or inability to refrain from tobacco use 2 hours pre dose until 4 hours post dose.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Single Dose, Open Label Pharmacokinetic Study of Omaveloxolone in Subjects With Mild, Moderate, or Severe Hepatic Impairment, or With Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Omaveloxolone 50 mg capsules
- Keywords
- RTA 408, RTA 408 capsules, Omaveloxolone, Omaveloxolone capsules, Hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omaveloxolone 50 mg capsulesDrug
Also called RTA 408
Capsules containing 50 mg of omaveloxolone
| Study group | Role | What they receive |
|---|---|---|
| Group 1: matched healthy subjects | Experimental | On the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. Receives: Drug: Omaveloxolone 50 mg capsules |
| Group 2: subjects with mild hepatic impairment | Experimental | On the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. Receives: Drug: Omaveloxolone 50 mg capsules |
| Group 3: subjects with moderate hepatic impairment | Experimental | On the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. Receives: Drug: Omaveloxolone 50 mg capsules |
| Group 4: subjects with severe hepatic impairment | Experimental | On the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. Receives: Drug: Omaveloxolone 50 mg capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of omaveloxolone in plasma
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Measured: 15 days
Area under the the plasma omaveloxolone concentration-time curve (AUC)
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Measured: 15 days
Secondary outcomes (1)
Count of reported adverse events
Safety and tolerability will be assessed by counting adverse events, as defined the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start19 Jul 2019
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902002
- Sponsor's protocol ID
- 408-C-1804
- Status last verified
- May 2025
- First submitted
- 26 Mar 2019
- Last updated
- 30 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open Label Pharmacokinetic Study of Omaveloxolone in Subjects With Mild, Moderate, or Severe Hepatic Impairment, or With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT03902002
- Acronym / sponsor ID
- 408-C-1804
- Conditions
- Hepatic Impairment
- Keywords
- RTA 408, RTA 408 capsules, Omaveloxolone, Omaveloxolone capsules, Hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 3 Apr 2019 (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 study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: matched healthy subjects | Experimental | Drug: Omaveloxolone 50 mg capsulesOn the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. |
| Group 2: subjects with mild hepatic impairment | Experimental | Drug: Omaveloxolone 50 mg capsulesOn the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. |
| Group 3: subjects with moderate hepatic impairment | Experimental | Drug: Omaveloxolone 50 mg capsulesOn the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. |
| Group 4: subjects with severe hepatic impairment | Experimental | Drug: Omaveloxolone 50 mg capsulesOn the morning of Day 1, following an overnight fast of at least 10 hours, a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) will be administered with 240 mL of water. No food will be allowed for 4 hours post dose. Pharmacokinetic samples will be obtained from pre dose until 336 hours post dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females, of any race, between 18 and 70 years of age, inclusive.
- BMI between 18.0 and 38.0 kg/m2, inclusive, and body weight ≥ 50 kg.
- Females will not be pregnant (or planning to get pregnant) or lactating at Screening or Check in (Day 1), and females of childbearing potential and males will agree to use contraception .
- Male subjects must not donate sperm and female subjects must not donate ova from Check in (Day 1) until 90 days after their dose of study drug.
- Subjects with Normal Hepatic Function Only
Key exclusion criteria (43 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- Ventricular dysfunction or history of risk factors for Torsade de Pointes (TdP; e.g., unexplained syncope, known long QT syndrome, heart failure, and cardiomyopathy). Subjects will be excluded if there is a family history of long QT syndrome.
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 |
|---|---|---|
| Omaveloxolone 50 mg capsulesAlso: RTA 408Capsules containing 50 mg of omaveloxolone | Drug | Group 1: matched healthy subjects, Group 2: subjects with mild hepatic impairment, Group 3: subjects with moderate hepatic impairment, Group 4: subjects with severe hepatic impairment |
Primary outcome
Maximum concentration (Cmax) of omaveloxolone in plasma
Time frame: 15 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Area under the the plasma omaveloxolone concentration-time curve (AUC)
Time frame: 15 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
1 secondary outcome
Count of reported adverse events
Time frame: 15 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 30 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omaveloxolone 50 mg capsules in people with Hepatic Impairment, run by Biogen at 3 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 12 inclusion and 43 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 30 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 3 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?
Maximum concentration (Cmax) of omaveloxolone in plasma (time frame: 15 days). The study lists 2 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 30 May 2025.