A Study of Epetraborole Tablets in Subjects With Degrees of Renal Function

Exclusion Criteria

• •All subjects:
• •1. Female who is lactating or is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
• •2. Any CS medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
• •3. QTcF interval duration \> 500 msec obtained as an average from the triplicate ECGs taken at least 1 minute apart after at least 5 minutes in a semi-supine, quiet rest position at Screening or prior to the first study drug administration
• •4. Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin greater than 1.5 × the upper limit of normal (ULN) for the reference laboratory, or history of chronic liver disease, cirrhosis, or biliary disease. For subjects with Gilbert's Syndrome, the subject may be included in the study at the discretion of the Investigator if the bilirubin levels are within the range for this condition.
• •5. Recent history (within 6 months) of known or suspected Clostridioides difficile infection
• •6. History of seizure disorder except childhood history of febrile seizures
• •7. Positive drug/alcohol testing at Screening or prior to the first study drug administration unless the positive drug screen is due to prescription drug use that is approved by the Investigator and the Sponsor's Medical Monitor
• •8. Positive testing for HIV, hepatitis B surface antigen, or hepatitis C virus antibody at Screening
• •9. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months prior to Screening
• •10. History of hypersensitivity reaction or anaphylaxis to any medication, unless deemed not CS by an Investigator
• •11. Donation of blood or plasma within 30 days prior to the first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to the first study drug administration
• •12. Receipt of an investigational drug within 30 days or 5 half-lives prior to the first administration of study drug, whichever is longer
• •13. Any other condition or prior therapy, which, in the opinion of an Investigator, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements
• •Cohort 1:
• •14. Hemoglobin, hematocrit, white blood cell count, or platelet count less than the lower limit of normal range of the reference laboratory, unless deemed not CS by an Investigator
• •15. Current or anticipated concomitant medications, defined as the use of any over the counter (OTC) medications within 7 days prior to study drug administration or use of prescription medications, health supplements, and herbal remedies taken within 14 days prior to study drug administration Exceptions: Hormonal contraceptives and intermittent, as-needed acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of transient headache or other minor ache/pain. Discussion between the Principal Investigator and the Sponsor's Medical Monitor is encouraged regarding the acceptability of any medications prior to study drug administration.
• •Cohorts 2 to 5:
• •16. Hemoglobin \< 10.0 g/dL, white blood cell \< 3,000 cells/L, or platelet count \< 100,000 cells/L
• •17. Current or anticipated concomitant medications with the exception of hormonal contraceptives, as-needed acetaminophen or NSAIDs for the treatment of transient, minor aches/pain, or any medication deemed essential for the management of renal impairment and the treatment of concomitant stable medical conditions as per the discretion of the Investigator.