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)

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

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

2. Agree to abide by the study restrictions.

3. Are between the ages of 18 and 85 years, inclusive, at the time of enrollment.

4. Must have mild, moderate, or severe renal impairment or end stage renal disease (ESRD), but are not on dialysis.

5. Have no history of chronic tobacco/nicotine usage (i.e., >10 cigarettes per day for 3 months minimum prior to admission).

6. Have corrected QT interval by Fridericia (QTcF) <460 msec on Electrocardiogram (ECG).

7. Have a Body Mass Index (BMI) of 18 to 40 kg/m^2 at enrollment.

8. Women of childbearing potential** must use an acceptable contraception method*** forthe duration of the study.

**Not sterilized via tubal ligation, bilateral oophorectomy, bilateralsalpingectomy, hysterectomy, implanted contraceptive device placement (permanent,non-surgical, non-hormonal sterilization) with documented radiological confirmationtest at least 90 days after the procedure, and still menstruating or <1 year haspassed since the last menses if menopausal.

***Includes, non-male sexual relationships, abstinence from sexual intercourse witha male partner, monogamous relationship with vasectomized partner who has beenvasectomized for 180 days or more prior to the participant receiving study product,barrier methods such as condoms with spermicide or diaphragms/cervical caps withspermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonalmethods such as implants, injectables, or oral contraceptives ("the pill").

9. If participant is male and capable of reproduction, agrees to avoid fathering achild for the duration of the study by using an acceptable method of birthcontrol****.

****In addition to the use of a barrier method (condom) unless vasectomized,acceptable methods of birth control are restricted to a monogamous relationship witha woman who agrees to use acceptable contraception as outlined in inclusioncriterion #8, and/or abstinence from sexual intercourse with women.

10. Women of childbearing potential must have a negative urine pregnancy test within 24hours prior to receipt of study product.

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

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

*As evidence by signature on an informed consent document approved by theInstitutional Review Board (IRB).

2. Agree to abide by the study restrictions.

3. Are healthy male or non-pregnant female, between the ages of 18 and 85 years,inclusive, with normal GFR >90 at screening.

4. Have no history of chronic tobacco/nicotine usage (i.e., >10 cigarettes per day for 3 months minimum prior to admission).

5. Have a normal corrected QT interval by Fridericia (QTcF) <460 msec on ECG.

6. Have a Body Mass Index of 18 to 40 kg/m^2 at enrollment.

7. Women of childbearing potential** must use an acceptable contraception method*** forthe duration of the study.

**Not sterilized via tubal ligation, bilateral oophorectomy, bilateralsalpingectomy, hysterectomy, implanted contraceptive device placement (permanent,non-surgical, non-hormonal sterilization) with documented radiological confirmationtest at least 90 days after the procedure, and still menstruating or <1 year haspassed since the last menses if menopausal.

***Includes non-male sexual relationships, abstinence from sexual intercourse with amale partner, monogamous relationship with vasectomized partner who has beenvasectomized for 180 days or more prior to the participant receiving study product,barrier methods such as condoms with spermicide or diaphragms/cervical caps withspermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonalmethods such as implants, injectables, or oral contraceptives ("the pill").

8. If participant is male and capable of reproduction, agrees to avoid fathering achild for the duration of the study by using an acceptable method of birthcontrol****.

****In addition to the use of a barrier method (condom) unless vasectomized,acceptable methods of birth control are restricted to a monogamous relationship witha woman who agrees to use acceptable contraception as outlined in inclusioncriterion #7, and/or abstinence from sexual intercourse with women.

9. Women of childbearing potential must have a negative urine pregnancy test within 24hours prior to receipt of study product.

Exclusion Criteria:

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

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 bythe 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 ratebetween 45 and 49, inclusive, is acceptable only in younger athleticparticipants, 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 youngerathletic 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 abovebaseline** (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 hospitaladmission except for approved prescriptions that are not opiates andbenzodiazepines.

14. Significant history of drug and/or food allergies (as deemed by the PrincipalInvestigator (PI)).

15. For women, participant is pregnant (positive test for urine Human ChorionicGonadotropin [HCG]) at screening or Admission, breastfeeding, or planning toconceive for the duration of the study.

16. Any contraindication to the use of nitroimidazoles, or prior treatment withpretomanid or delamanid.

17. Treatment with strong or moderate CYP3A4 inducers or inhibitors*** within 14 daysbefore 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 untilVisit 01N.

20. Donation of whole blood or blood products >500 mL within 30 days from screeningand/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 todosing 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), orHuman 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 allstudy 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 UpperLimit of Normal (ULN).

29. Hyperbilirubinemia >1.5 x Upper Limits of Normal (ULN).

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

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 bythe 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 youngerathletic 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 hospitaladmission except for approved prescriptions that are not opiates andbenzodiazepines.

12. Significant history of drug and/or food allergies (as deemed by the PrincipalInvestigator (PI)).

13. Women of childbearing potential with a positive urine pregnancy test within 24 hoursprior to receipt of study product.

14. Any contraindication to the use of nitroimidazoles, or prior treatment withpretomanid or delamanid.

15. Treatment with strong or moderate CYP3A4 inducers or inhibitors** within 14 daysbefore 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 untilVisit 01N.

18. Donation of whole blood or blood products >500 mL within 30 days from screeningand/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 todosing 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), orHuman 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 allstudy 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 Limitsof Normal (ULN).

26. Bilirubin > Upper Limits of Normal (ULN)