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

Inclusion Criteria

Participant Inclusion Criteria for Patients with Renal Impairment (Groups 2-4)

• Have the ability to understand the requirements of the study and have provided written informed consent* before any study-related procedure is performed.

*As evidence by signature on an informed consent document approved by the Institutional Review Board

• Agree to abide by the study restrictions.
• Are between the ages of 18 and 85 years, inclusive, at the time of enrollment.
• Must have mild, moderate, or severe renal impairment or end stage renal disease (ESRD), but are not on dialysis.
• Have no history of chronic tobacco/nicotine usage (i.e., >10 cigarettes per day for 3 months minimum prior to admission).
• Have corrected QT interval by Fridericia (QTcF) 90 at screening.
• Have no history of chronic tobacco/nicotine usage (i.e., >10 cigarettes per day for 3 months minimum prior to admission).
• Have a normal corrected QT interval by Fridericia (QTcF) 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
• History of, or screening results show a corrected QT interval by Fridericia (QTcF) >/= 460 msec.
• Family history of Long-QT Syndrome or sudden death when a cause of death is unknown.
• Inability to swallow tablets.
• History of fever or documented fever (oral temperature >/= 100.4 degrees F) in the 48 hours prior to admission to the hospital.
• Resting pulse rate 110 bpm at Screening.
• 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.

• Current hyperkalemia or hypomagnesemia.
• Positive result of urine drug screen or blood alcohol screen prior to hospital admission except for approved prescriptions that are not opiates and benzodiazepines.
• Significant history of drug and/or food allergies (as deemed by the Principal Investigator (PI)).
• 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.
• Any contraindication to the use of nitroimidazoles, or prior treatment with pretomanid or delamanid.
• 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

• Use of St. John's Wort within 7 days prior to admission and during the entire study.
• Consumption of products containing grapefruit within 5 days prior to dosing until Visit 01N.
• 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.
• Participation in another interventional clinical trial within 30 days prior to dosing until after the last study visit.
• Hemoglobin (Hgb) 2.5 x Upper Limit of Normal (ULN).
• Hyperbilirubinemia >1.5 x Upper Limits of Normal (ULN).

Participant Exclusion Criteria for Healthy Participants (Groups 1A-1C)

• History of known active TB.
• History of peptic ulcer disease.
• Known hypersensitivity to pretomanid or any of the excipients.
• History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI)).
• Any clinically significant ECG abnormality at screening.*

*Note: the following can be considered not clinically significant:

• Heart rate 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
• Family history of Long-QT Syndrome or sudden death when a cause of death is unknown.
• Inability to swallow tablets.
• History of fever or documented fever (oral temperature >/= 100.4 degrees F) in th