- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461161
A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
February 1, 2024 updated by: Reata, a wholly owned subsidiary of Biogen
This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
Study Overview
Detailed Description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
West Bend, Wisconsin, United States, 53095
- Spaulding Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Males or Females between 18 and 45 years of age;
- Willing to practice methods 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 prior to enrollment into the trial;
- Body mass index (BMI) between 19 and 31 kg/m2;
- Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records that describe events captured in the endpoints;
- Willing and able to cooperate with all aspects of the protocol.
Exclusion Criteria:
- Participated in another clinical trial of an investigational drug (or a medical device) within the last 30 days, or are currently participating in another trial of an investigational drug (or a medical device);
- Any condition possibly affecting absorption, distribution, metabolism or excretion of drugs that may confound the analyses conducted in this study [e.g., previous surgery on the gastrointestinal tract that includes removal of parts of stomach, bowel, liver, gall bladder, or pancreas];
- Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
- 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;
- 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;
- Any vaccination within 30 days before start of this study and throughout the study;
- 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;
- 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;
- Donation or receipt of blood or blood components within the 4 weeks prior to the study. 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 prior to study participation;
- Sustained systolic blood pressure > 140 mmHg or < 100 mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline measured after 5 minutes in a sitting position. Blood pressure may be re-tested twice in a sitting 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;
- A pulse rate at rest of < 45 bpm or > 100 bpm;
- Abnormal screening ECG which is interpreted by the investigator to be clinically significant;
- Used tobacco-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) or products for smoking cessation 2 weeks prior to Day -1 of Period 1 of the study;
- Consumed alcohol or xanthine-containing products (e.g., tea, coffee, chocolate, cola, etc.) within 72 hours prior to Day -1 of Period 1 of the study;
- Treated within 30 days before Day -1 of Period 1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer) with any investigational agent;
- A positive history of drug abuse or who test positive for drug(s) of abuse, ethanol, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, cannabinoids or cotinine (indicating active current smoking) at the screening or Day -1 of Period 1 visit;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20 mg bardoxolone methyl
|
oral, single dose
|
Experimental: 60 mg bardoxolone methyl
|
oral, single dose
|
Experimental: 80 mg bardoxolone methyl
|
oral, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of food on Pharmacokinetics of a 20 mg single dose of bardoxolone methyl
Time Frame: 28 Days
|
28 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose proportionality of 20mg, 60mg, and 80mg bardoxolone methyl
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2011
Primary Completion (Actual)
December 31, 2011
Study Completion (Actual)
December 31, 2011
Study Registration Dates
First Submitted
October 25, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (Estimated)
October 27, 2011
Study Record Updates
Last Update Posted (Actual)
February 2, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 402-C-1004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on bardoxolone methyl
-
Reata, a wholly owned subsidiary of BiogenCompleted
-
Reata, a wholly owned subsidiary of BiogenWithdrawnDiabetes Mellitus, Type 2 | Renal Insufficiency, Chronic
-
Reata, a wholly owned subsidiary of BiogenCompletedHealthy | Hepatic ImpairmentUnited States
-
Reata, a wholly owned subsidiary of BiogenWithdrawnDiabetes Mellitus, Type 2 | Renal Insufficiency, Chronic
-
Reata, a wholly owned subsidiary of BiogenTerminatedChronic Kidney Diseases | Autosomal Dominant Polycystic Kidney | Alport SyndromeUnited States, France, Australia, Japan, Spain, Puerto Rico
-
Reata, a wholly owned subsidiary of BiogenCompletedDiabetic NephropathyUnited States
-
Reata, a wholly owned subsidiary of BiogenCompletedDiabetes Mellitus, Type 2 | Renal Insufficiency, ChronicUnited States
-
Reata, a wholly owned subsidiary of BiogenTerminatedDiabetes Mellitus, Type 2 | Renal Insufficiency, Chronic
-
Reata, a wholly owned subsidiary of BiogenWithdrawn
-
Kyowa Kirin Co., Ltd.TerminatedDiabetic Kidney DiseaseJapan