A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01461161
• Date of registration: 25/10/2011
• Primary sponsor: Reata Pharmaceuticals, Inc.
• Public title: A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
• Scientific title: A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
• Date of first enrolment: October 2011
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01461161
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males or Females between 18 and 45 years of age;

2. 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;

3. 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;

4. Body mass index (BMI) between 19 and 31 kg/m2;

5. 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;

6. Willing and able to cooperate with all aspects of the protocol.

Exclusion Criteria:

1. 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);

2. 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];

3. Known hypersensitivity to any component in the formulation of the study drug,
bardoxolone methyl;

4. 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;

5. 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);

6. Positive test results for human immunodeficiency virus type 1 or 2 antibody,
hepatitis B surface antigen, or hepatitis C virus antibody at screening;

7. Any medical or dental procedure, no matter how minor, that is planned or anticipated
to occur during the conduct of the study;

8. History of drug or alcohol abuse or dependence within the last year;

9. Any vaccination within 30 days before start of this study and throughout the study;

10. 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;

11. 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;

12. 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;

13. Any diagnostic or intervention procedure requiring a contrast agent within the 30
days prior to study participation;

14. 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;

15. A pulse rate at rest of < 45 bpm or > 100 bpm;

16. Abnormal screening ECG which is interpreted by the investigator to be clinically
significant;

17. 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;

18. 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;

19. 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;

20. 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;

21. Female subjects who are planning a pregnancy or are pregnant or lactating;

22. 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;

23. 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: bardoxolone methyl

Primary Outcome(s)

Effect of food on Pharmacokinetics of a 20 mg single dose of bardoxolone methyl [Time Frame: 28 Days]

Secondary Outcome(s)

Dose proportionality of 20mg, 60mg, and 80mg bardoxolone methyl [Time Frame: 28 days]

Secondary ID(s)

402-C-1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors