Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function

Exclusion Criteria

• •1. History of known active TB.
• •2. History of peptic ulcer disease.
• •3. Known hypersensitivity to pretomanid or any of the excipients.
• •4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI)).
• •5. Any clinically significant electrocardiogram (ECG) abnormality at screening\*.
• •\*Note: the following can be considered not clinically significant:
• •\- Heart rate \</= 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic participants, as determined by the Principal Investigator ))
• •* Mild first-degree atrioventricular (A-V) block (P-R interval \>0.23 seconds)
• •* Right or left axis deviation
• •* Incomplete right bundle branch block
• •* Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic participants
• •6. History of, or screening results show a corrected QT interval by Fridericia (QTcF) \>/= 460 msec.
• •7. Family history of Long-QT Syndrome or sudden death when a cause of death is unknown.
• •8. Inability to swallow tablets.
• •9. History of fever or documented fever (oral temperature \>/= 100.4 degrees F) in the 48 hours prior to admission to the hospital.
• •10. Resting pulse rate \<50 or \>110 bpm at Screening.
• •11. At Screening, blood pressure \>/= 20 mm Hg systolic or \>10 mm Hg diastolic above baseline\*\* (sitting).
• •\*\*Baseline is most recent blood pressure in the last 3 months.
• •12. Current hyperkalemia or hypomagnesemia.
• •13. Positive result of urine drug screen or blood alcohol screen prior to hospital admission except for approved prescriptions that are not opiates and benzodiazepines.
• •14. Significant history of drug and/or food allergies (as deemed by the Principal Investigator (PI)).
• •15. For women, participant is pregnant (positive test for urine Human Chorionic Gonadotropin \[HCG\]) at screening or Admission, breastfeeding, or planning to conceive for the duration of the study.
• •16. Any contraindication to the use of nitroimidazoles, or prior treatment with pretomanid or delamanid.
• •17. Treatment with strong or moderate CYP3A4 inducers or inhibitors\*\*\* within 14 days before admission and during the study\*\*\*\*.
• •\*\*\*Except hormonal contraceptives
• •\*\*\*\*In the opinion of the site investigator
• •18. Use of St. John's Wort within 7 days prior to admission and during the entire study.
• •19. Consumption of products containing grapefruit within 5 days prior to dosing until Visit 01N.
• •20. Donation of whole blood or blood products \>500 mL within 30 days from screening and/or plans to donate during the study or up to 14 days after dosing.
• •21. Participation in another interventional clinical trial within 30 days prior to dosing until after the last study visit.
• •22. Hemoglobin (Hgb) \<8.0 g/dL in both men and women at the screening visit.
• •23. Positive Screening test for Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or Human Immunodeficiency Virus (HIV).
• •24. Renal transplant.
• •25. Scheduled for hemodialysis or peritoneal dialysis.
• •26. Presence of any condition or finding\*\*\*\*\* which would jeopardize participant safety, impact study result validity, or diminish the participant's ability to undergo all study procedures and assessments.
• •\*\*\*\*\*In the opinion of the investigator
• •27. For men, semen donation for the duration of the study.
• •28. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \> 2.5 x Upper Limit of Normal (ULN).
• •29. Hyperbilirubinemia \>1.5 x Upper Limits of Normal (ULN).
• •1. History of known active TB.
• •2. History of peptic ulcer disease.
• •3. Known hypersensitivity to pretomanid or any of the excipients.
• •4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI)).
• •5. Any clinically significant ECG abnormality at screening.\*
• •\*Note: the following can be considered not clinically significant:
• •* Heart rate \</= 50 bpm (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic participants)
• •* Mild first-degree A-V block (P-R interval \>0.23 seconds)
• •* Right or left axis deviation
• •* Incomplete right bundle branch block
• •* Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic participants
• •6. Family history of Long-QT Syndrome or sudden death when a cause of death is unknown.
• •7. Inability to swallow tablets.
• •8. History of fever or documented fever (oral temperature \>/= 100.4 degrees F) in the 48 hours prior to admission to the hospital.
• •9. At Screening blood pressure \>140/90 mm Hg or \<90/65 mm Hg (sitting).
• •10. History of, or screening results show a corrected QT interval by Fridericia (QTcF) \>460 msec.
• •11. Positive result of urine drug screen or blood alcohol screen prior to hospital admission except for approved prescriptions that are not opiates and benzodiazepines.
• •12. Significant history of drug and/or food allergies (as deemed by the Principal Investigator (PI)).
• •13. Women of childbearing potential with a positive urine pregnancy test within 24 hours prior to receipt of study product.
• •14. Any contraindication to the use of nitroimidazoles, or prior treatment with pretomanid or delamanid.
• •15. Treatment with strong or moderate CYP3A4 inducers or inhibitors\*\* within 14 days before admission and during the study\*\*\*.
• •\*\*Except hormonal contraceptives
• •\*\*\*In the opinion of the site Principal Investigator (PI)
• •16. Use of St. John's Wort within 7 days prior to admission and during the entire study.
• •17. Consumption of products containing grapefruit within 5 days prior to dosing until Visit 01N.
• •18. Donation of whole blood or blood products \>500 mL within 30 days from screening and/or plans to donate during the study or up to 14 days after dosing.
• •19. Participation in another interventional clinical trial within 30 days prior to dosing until after the last study visit.
• •20. Hgb \<10.0 g/dL in both men and women at the screening visit.
• •21. Positive Screening test for Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency Virus (HIV).
• •22. Renal transplant.
• •23. Presence of any condition or finding\*\*\*\* which would jeopardize participant safety, impact study result validity, or diminish the participant's ability to undergo all study procedures and assessments.
• •\*\*\*\*In the opinion of the investigator
• •24. For men, semen donation for the duration of the study.
• •25. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \> Upper Limits of Normal (ULN).
• •26. Bilirubin \> Upper Limits of Normal (ULN)