PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days to treatment-naive patients with drug-sensitive pulmonary tuberculosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
600 mg twice daily (BID) for 14 days
1200 mg once daily (QD) for 14 days
Combination tablet (RHZE) dosed by weight. Dosage strength per tablet is 150 mg Rifampicin (R)/75 mg Isoniazid (H)/400 mg Pyrazinamide (Z)/275 mg Ethambutol (E)
Pfizer Investigational Site
Bellville, Cape Town, South Africa
Pfizer Investigational Site
Cape Town, South Africa
The primary endpoint is rate of change in sputum log CFU/mL count (EBA) from Days 0-2.
Time frame: Days 0-2
Rate of change in sputum log CFU/mL count (extended EBA).
Time frame: Days 2-14
Rate of change in sputum log CFU/mL count (extended EBA).
Time frame: Days 0-14
Rate of change in culture time to positivity (TTP) measured by MGIT and in log transformed TTP
Time frame: Days 02-; 2-14; 0-14
Cumulative whole blood bactericidal activity (measured as log reduction in CFU) against intracellular M. tuberculosis relative to administered dose and drug PK
Time frame: Day 1
Cumulative whole blood bactericidal activity (measured as log reduction in CFU) against intracellular M. tuberculosis relative to administered dose and drug PK
Time frame: Day 13-14
Plasma concentrations of PNU-100480 and PNU-101603 will be used to determine PK parameters (AUCtau, AUC tau,ss, Cmax, Tmax, terminal half-life t1/2, Cavg, Rac) as data permit
Time frame: Day 1
Plasma concentrations of PNU-100480 and PNU-101603 will be used to determine PK parameters (AUCtau, AUC tau,ss, Cmax, Tmax, terminal half-life t1/2, Cavg, Rac) as data permit
Time frame: Day 13-14
Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.
Time frame: Phys exam, AEs, and vitals are done at every visit (Screening through Day 15, Day 42/Follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.
Time frame: ECGs are done at Screening, Day 1, Day 14, 15 and 42/Follow-up
Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.
Time frame: Lab tests at Screening, Day 1, Day 15 and 42/Follow-up