Status and phase
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About
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
Full description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All subjects must meet all of the following criteria to be included in the study:
Exclusion criteria
All subjects with any of the following conditions or characteristics must be excluded from the study:
Currently participating in another study of an investigational drug (or a medical device) or have participated in another clinical study of an investigational drug (or a medical device) within 30 days of Study Day -1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer);
Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
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;
History of smoking or tobacco use within the 6 months prior to Study Day -1;
Donation or receipt of blood or blood components within the 4 weeks prior to 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;
History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or Torsades de Pointes, structural heart disease, or family history of long QT syndrome (suggested by sudden death due to cardiac causes at a young age of a close relative);
Evidence of any of the following cardiac conduction abnormalities based on the safety ECG at Screening:
Screening ECG renders measurement of QT interval in lead II imprecise (for example: flat T waves, arrhythmias);
Subjects who have a screening supine blood pressure (BP) outside 90-145 mm Hg systolic or 45-95 mm Hg diastolic (measured following at least a 10-minute rest). Blood pressure may be re-tested twice in the supine 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 and the subject may not be randomized;
Use of any concomitant medications that are known to prolong QT/QTc interval within 30 days prior to Study Day -1;
Allergy to moxifloxacin or any fluoroquinolone antibiotic;
A positive test for drug(s) of abuse (alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids) at the screening or the Day -2 visit;
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;
Positive test results for human immunodeficiency virus type 1 or 2 antibody at screening;
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, venocaval shunts, or transjugular intrahepatic portosystemic shunts]);
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 transferase (GGT), lactate dehydrogenase (LDH), or alkaline phosphatase levels to greater than the upper limit of normal (ULN) at screening;
Abnormal hematological and biochemical parameters, including neutrophil count < 1500 cells/mm3, Hgb < 11 g/dL in females or < 12 g/dL in males, platelet count < 90,000 cells/mm3, creatinine ≥ 1.5 X ULN, albumin ≤ 3 g/dL, serum amylase or lipase ≥ 1.5X ULN at screening;
Positive test results for hepatitis B virus antibody, or hepatitis C virus antibody at screening;
Use of or need for any prescription or non-prescription systemic drug(s) including vitamins or herbal preparations other than drugs used for contraception, aspirin, acetaminophen, or other non-steroidal anti-inflammatory agents, within 10 days before Study Day -1 or during the study;
Use of aspirin, non-steroidal anti-inflammatory agents, or acetaminophen within 5 days prior to Study Day -1;
Consumption of alcohol- or caffeine-containing compounds within 24 hours before Day -2 visit;
Consumption of citrus juice within the 7 days before Day -2 visit.
Primary purpose
Allocation
Interventional model
Masking
179 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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