Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1
Total Enrollment
14 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-29
Study Completion Date
2023-11-17
Brief Summary
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This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects. There will be approximately 36 total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be conducted at 2 sites, study duration is approximately 24 months, and subject participation duration is approximately 5 weeks (including screening). Primary objective: To evaluate the pharmacokinetics of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects.
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Detailed Description
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This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects. This study will enroll approximately 6 subjects with mild hepatic impairment (Child-Pugh A), approximately 6 subjects with moderate hepatic impairment (Child-Pugh B), approximately 6 subjects with severe hepatic impairment (Child-Pugh C), and approximately 18 matched non-hepatically impaired subjects. Non-hepatically impaired subjects in the control group will be matched to subjects with hepatic impairment based on age (+/- 10 years) and body weight (+/- 20 percent) as measured at screening (Visit 00A). There will be approximately 36 total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be conducted at 2 sites, study duration is approximately 24 months, and subject participation duration is approximately 5 weeks (including screening). Primary objective: To evaluate the pharmacokinetics of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects.
Conditions
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Tuberculosis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Child-Pugh A (Mild hepatic impairment)
6 Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group Type
EXPERIMENTAL
PA-824
Intervention Type
DRUG
Pretomanid (PA-824) is a nitroimidazooxazine. All subjects will receive a single oral dose of 200 mg Pretomanid on day 1.
Child-Pugh B (Moderate hepatic impairment)
6 Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group Type
EXPERIMENTAL
PA-824
Intervention Type
DRUG
Pretomanid (PA-824) is a nitroimidazooxazine. All subjects will receive a single oral dose of 200 mg Pretomanid on day 1.
Child-Pugh C (Severe hepatic impairment)
6 Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group Type
EXPERIMENTAL
PA-824
Intervention Type
DRUG
Pretomanid (PA-824) is a nitroimidazooxazine. All subjects will receive a single oral dose of 200 mg Pretomanid on day 1.
Non-hepatically impaired controls
18 matched Subjects will receive a single oral dose of 200mg Pretomanid tablets on day 1
Group Type
EXPERIMENTAL
PA-824
Intervention Type
DRUG
Pretomanid (PA-824) is a nitroimidazooxazine. All subjects will receive a single oral dose of 200 mg Pretomanid on day 1.
Interventions
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PA-824
Pretomanid (PA-824) is a nitroimidazooxazine. All subjects will receive a single oral dose of 200 mg Pretomanid on day 1.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Subject is able to give voluntary written informed consent before any study related procedure is performed.
2. 18-70 years of age, inclusive.
3. Acceptable laboratory values\* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit.
\*Chemistry, complete blood count, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, and urinalysis deemed not clinically significant by the investigator.
4. Hepatic impairment classified as Child-Pugh class A (mild), B (moderate), or C (severe) criteria at screening for Groups 1, 2, or 3, respectively, and documented evidence of hepatic cirrhosis\*.
\*by biopsy, nuclear scan, CT, MRI, ultrasound, or other clinically acceptable methods
5. If female, not of childbearing potential\* or agrees to avoid becoming pregnant by using acceptable contraception\*\* during the duration of the study.
\*Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy.
* Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men.
6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control\*.
\*In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in inclusion criterion #5, and abstinence from sexual intercourse with women.
7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit.
8. Willingness to comply with all protocol requirements.
1. Subject is able to give voluntary written informed consent before any study related procedure is performed.
2. 18-70 years of age, inclusive.
3. Subject is a healthy volunteer as determined by no clinically significant findings from medical history, physical examination, vital signs, and 12-lead ECG as determined by the Site Investigator.
4. Acceptable laboratory values\* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit.
\*Chemistry, complete blood count, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, and urinalysis within the reference range for the test laboratory, unless deemed not clinically significant by the investigator.
5. If female, not of childbearing potential\* or agrees to avoid becoming pregnant by using acceptable contraception\*\* during the duration of the study.
\*Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy.
\*\*Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men.
6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control\*.
\*In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in inclusion criterion #5, and abstinence from sexual intercourse with women.
7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit.
8. Willingness to comply with all protocol requirements.
2. 18-70 years of age, inclusive.
3. Acceptable laboratory values\* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit.
\*Chemistry, complete blood count, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, and urinalysis deemed not clinically significant by the investigator.
4. Hepatic impairment classified as Child-Pugh class A (mild), B (moderate), or C (severe) criteria at screening for Groups 1, 2, or 3, respectively, and documented evidence of hepatic cirrhosis\*.
\*by biopsy, nuclear scan, CT, MRI, ultrasound, or other clinically acceptable methods
5. If female, not of childbearing potential\* or agrees to avoid becoming pregnant by using acceptable contraception\*\* during the duration of the study.
\*Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy.
* Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men.
6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control\*.
\*In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in inclusion criterion #5, and abstinence from sexual intercourse with women.
7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit.
8. Willingness to comply with all protocol requirements.
1. Subject is able to give voluntary written informed consent before any study related procedure is performed.
2. 18-70 years of age, inclusive.
3. Subject is a healthy volunteer as determined by no clinically significant findings from medical history, physical examination, vital signs, and 12-lead ECG as determined by the Site Investigator.
4. Acceptable laboratory values\* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit.
\*Chemistry, complete blood count, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, and urinalysis within the reference range for the test laboratory, unless deemed not clinically significant by the investigator.
5. If female, not of childbearing potential\* or agrees to avoid becoming pregnant by using acceptable contraception\*\* during the duration of the study.
\*Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy.
\*\*Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men.
6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control\*.
\*In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in inclusion criterion #5, and abstinence from sexual intercourse with women.
7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit.
8. Willingness to comply with all protocol requirements.
Exclusion Criteria
1. Hypokalemia (\< 3.5mEq/L), severe hypomagnesemia (\< 1.1 mg/dL) or severe hypocalcemia (\< 7.5 mg/dL).
2. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 10 times the upper limit of normal.
3. Creatinine clearance \< 60 ml/min.
4. Inability to swallow tablets.
5. Presence of any condition or finding\* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments\*\*.
\*in the opinion of the site investigator
\*\*e.g., inability to draw Pharmacokinetics (PK) samples
6. History of fever or documented fever (oral temperature \> / = 100.4 degrees F or \> / = 38.0 degrees C) in the 48 hours prior to admission to the the confinement/hospital unit.
7. Currently breastfeeding.
8. History of chronic tobacco/nicotine use (\> 10 cigarettes per day for 3 months minimum prior to admission).
9. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors).
10. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening.
11. Use of any over the counter (OTC) medication\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
\*including vitamins and herbal supplements, cough and cold medications.
\*\*in the opinion of the site investigator
12. Treatment with CYP450 enzyme altering drugs\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
* except hormonal contraceptives
* in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section.
13. A positive blood screen for HIV.
14. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse\* at screening and at admission to the confinement/hospital unit.
\*Amphetamines, barbiturates, cocaine metabolites, marijuana, opiates, phencyclidine (PCP).
NOTE: Results of the urine screen test can be ignored if in the opinion of the PI the results can be explained by the concomitant medications history.
15. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weightlifting, competitive sports) during the course of the study.
16. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12.
17. A Heart Rate-Corrected QT Interval (Fridericia's Formula) (QTcF) interval \> 450 msec (males) or \> 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval.
18. A family history\* of Long QT Syndrome, premature cardiac death\*\*, or sudden death without a preceding diagnosis of a condition\*\*\* that could be causative of sudden death.
\*parents
\*\*due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women)
\*\*\*such as known coronary artery disease, congestive heart failure, or terminal cancer
19. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit.
20. Donation of \> 500 mL blood within the 30 days prior to admission to the confinement/hospital unit.
21. Plans to donate blood during the study or up to 14 days after dosing.
22. Persons with a transjugular intrahepatic portosystemic shunt.
1. Inability to swallow tablets.
2. Presence of any condition or finding\* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments\*\*.
\*in the opinion of the site investigator
\*\*e.g., inability to collect Pharmacokinetics (PK) samples
3. History of fever or documented fever (oral temperature \> / = 100.4 degrees F or \> / = 38.0 degrees C) in the 48 hours prior to admission to the confinement/hospital unit.
4. Currently breastfeeding.
5. History of chronic tobacco/nicotine use (\> 10 cigarettes per day for 3 months minimum prior to admission to the confinement/hospital unit).
6. History of seizures (other than febrile seizures during childhood) or known or suspected Central Nervous System (CNS) disorders that may predispose to seizures.
7. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors).
8. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening.
9. Use of any over the counter (OTC) medication\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
\*including vitamins and herbal supplements, antacids, cough and cold medications.
\*\*in the opinion of the site investigator
10. Use of prescription medication except hormonal contraceptives within 30 days prior to admission to the confinement/hospital unit, unless\* the substance would not likely impact study result validity.
\*in the opinion of the site investigator
11. Treatment with CYP450 enzyme altering drugs\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
\*except hormonal contraceptives
\*\*in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section.
12. A positive blood screen for HIV.
13. A positive blood screen for hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
14. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse\* at screening and at admission to the confinement/hospital unit.
\*Amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP).
15. A history of alcohol abuse or dependence within the past 1 month prior to admission to the confinement/hospital unit.
16. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weightlifting, competitive sports) during the course of the study.
17. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12.
18. A Heart Rate-Corrected QT Interval (Fridericia's Formula) (QTcF) interval \> 450 msec (males) or \> 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval.
19. A family history\* of Long QT Syndrome, premature cardiac death\*\*, or sudden death without a preceding diagnosis of a condition\*\*\* that could be causative of sudden death.
\*parents
\*\*due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women)
\*\*\*such as known coronary artery disease, congestive heart failure, or terminal cancer
20. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit.
21. Donation of \> 500 mL of blood within the 30 days prior to admission to the confinement/hospital unit.
22. Plans to donate blood during the study or up to 14 days after dosing.
23. Persons with a transjugular intrahepatic portosystemic shunt.
2. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 10 times the upper limit of normal.
3. Creatinine clearance \< 60 ml/min.
4. Inability to swallow tablets.
5. Presence of any condition or finding\* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments\*\*.
\*in the opinion of the site investigator
\*\*e.g., inability to draw Pharmacokinetics (PK) samples
6. History of fever or documented fever (oral temperature \> / = 100.4 degrees F or \> / = 38.0 degrees C) in the 48 hours prior to admission to the the confinement/hospital unit.
7. Currently breastfeeding.
8. History of chronic tobacco/nicotine use (\> 10 cigarettes per day for 3 months minimum prior to admission).
9. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors).
10. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening.
11. Use of any over the counter (OTC) medication\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
\*including vitamins and herbal supplements, cough and cold medications.
\*\*in the opinion of the site investigator
12. Treatment with CYP450 enzyme altering drugs\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
* except hormonal contraceptives
* in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section.
13. A positive blood screen for HIV.
14. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse\* at screening and at admission to the confinement/hospital unit.
\*Amphetamines, barbiturates, cocaine metabolites, marijuana, opiates, phencyclidine (PCP).
NOTE: Results of the urine screen test can be ignored if in the opinion of the PI the results can be explained by the concomitant medications history.
15. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weightlifting, competitive sports) during the course of the study.
16. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12.
17. A Heart Rate-Corrected QT Interval (Fridericia's Formula) (QTcF) interval \> 450 msec (males) or \> 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval.
18. A family history\* of Long QT Syndrome, premature cardiac death\*\*, or sudden death without a preceding diagnosis of a condition\*\*\* that could be causative of sudden death.
\*parents
\*\*due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women)
\*\*\*such as known coronary artery disease, congestive heart failure, or terminal cancer
19. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit.
20. Donation of \> 500 mL blood within the 30 days prior to admission to the confinement/hospital unit.
21. Plans to donate blood during the study or up to 14 days after dosing.
22. Persons with a transjugular intrahepatic portosystemic shunt.
1. Inability to swallow tablets.
2. Presence of any condition or finding\* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments\*\*.
\*in the opinion of the site investigator
\*\*e.g., inability to collect Pharmacokinetics (PK) samples
3. History of fever or documented fever (oral temperature \> / = 100.4 degrees F or \> / = 38.0 degrees C) in the 48 hours prior to admission to the confinement/hospital unit.
4. Currently breastfeeding.
5. History of chronic tobacco/nicotine use (\> 10 cigarettes per day for 3 months minimum prior to admission to the confinement/hospital unit).
6. History of seizures (other than febrile seizures during childhood) or known or suspected Central Nervous System (CNS) disorders that may predispose to seizures.
7. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors).
8. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening.
9. Use of any over the counter (OTC) medication\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
\*including vitamins and herbal supplements, antacids, cough and cold medications.
\*\*in the opinion of the site investigator
10. Use of prescription medication except hormonal contraceptives within 30 days prior to admission to the confinement/hospital unit, unless\* the substance would not likely impact study result validity.
\*in the opinion of the site investigator
11. Treatment with CYP450 enzyme altering drugs\* within 7 days prior to admission to the confinement/hospital unit, unless\*\* the substance would not likely impact the validity of the study results.
\*except hormonal contraceptives
\*\*in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section.
12. A positive blood screen for HIV.
13. A positive blood screen for hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
14. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse\* at screening and at admission to the confinement/hospital unit.
\*Amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP).
15. A history of alcohol abuse or dependence within the past 1 month prior to admission to the confinement/hospital unit.
16. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weightlifting, competitive sports) during the course of the study.
17. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12.
18. A Heart Rate-Corrected QT Interval (Fridericia's Formula) (QTcF) interval \> 450 msec (males) or \> 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval.
19. A family history\* of Long QT Syndrome, premature cardiac death\*\*, or sudden death without a preceding diagnosis of a condition\*\*\* that could be causative of sudden death.
\*parents
\*\*due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women)
\*\*\*such as known coronary artery disease, congestive heart failure, or terminal cancer
20. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit.
21. Donation of \> 500 mL of blood within the 30 days prior to admission to the confinement/hospital unit.
22. Plans to donate blood during the study or up to 14 days after dosing.
23. Persons with a transjugular intrahepatic portosystemic shunt.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Saint Louis University Center for Vaccine Development
St Louis, Missouri, United States
Site Status
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, United States
Site Status
Countries
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United States
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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13-0053
Identifier Type: -
Identifier Source: org_study_id
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Comparison of the Quantiferon®-TB GOLD (in Tube) Assay With Tuberculin Skin Testing for Detecting Latent Tuberculosis Infection in Patients With Chronic Liver Disease Being Evaluated for or Awaiting Liver Transplantation
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WITHDRAWN
NA
Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults
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COMPLETED
PHASE1
Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide
NCT04694586
SUSPENDED
PHASE2
Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB
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COMPLETED
PHASE2
Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
NCT00871949
COMPLETED
PHASE1
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
NCT03862248
WITHDRAWN
PHASE3
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
NCT03251196
UNKNOWN
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
NCT06114628
RECRUITING
PHASE2