PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
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.
Inclusion Criteria:

 -  Adult males or females between 18 and 65 years; women of childbearing potential must
 be willing to adhere to lifestyle requirements regarding contraception/pregnancy
 prevention.

 -  Newly diagnosed sputum smear-positive pulmonary TB confirmed with acid-fast bacillus
 (AFB) smear and chest x-ray. Patients with TB more than 5 years ago who completed
 treatment, are healthy, and meet other inclusion criteria may be included.

 -  Body weight between 40 and 90 kg, inclusive (in light clothing, no shoes).

 -  Reasonably normal hemoglobin (>=8 gm/dL), renal function (serum creatinine <2 mg/dL),
 hepatic function (serum AST <3xULN and total bilirubin <1.3 mg/dL), and random glucose
 <150 mg/dL.

 Exclusion Criteria:

 -  HIV infection with helper/inducer T-lymphocytes (CD4 cell) count of <=350x10-6/L.

 -  Presence of significant hemoptysis. Subjects who cough up frank blood (more than blood
 streaked sputum) will not be eligible.

 -  Pregnant or nursing females; females of childbearing potential unwilling or unable to
 adhere to contraception guidelines.

 -  Significant respiratory impairment (respiratory rate >35/minute).

 -  Clinical suspicion of disseminated TB or tuberculosis meningitis.

 -  Subjects with diabetes mellitus on insulin and/or who have poorly controlled disease.

 -  Subjects with confirmed or suspected multi-drug resistant TB.