Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Global Alliance for TB Drug Development

Criteria

Inclusion Criteria:

• Informed Consent

• Body weight between 40 and 90 kg, inclusive.

• Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.

• A chest X-ray compatible with TB.

• Sputum positive

• Adequate volume of sputum

• Female participants of childbearing potential negative serum pregnancy and agree to use birth control

• Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.

Exclusion Criteria:

• Poor general condition

• Rifampicin-resistant and/or Isoniazid-resistant

• MTB Treatment received within the 3 months prior

• Allergy to the IMP or related substances

• Evidence of extrathoracic TB

• A history of previous TB

• Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease

• History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination

• Any evidence of renal impairment

• For males, any evidence or history of abnormality in the reproductive system

• History and/or presence (or evidence) of neuropathy or epilepsy.

• Clinically relevant changes in the ECG

• A history of or current clinically relevant cardiovascular disorder

• Concomitant use of any drug known to prolong QTc interval

• Diabetics using insulin

• Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).

• Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.

• Any disease or conditions in which any of the medicinal products listed in the section pertaining to prohibited medication is used.

• alcohol or drug abuse

• Administration of an IMP prior to Visit 1, within 5 half-lives for that IMP if known. If the half-life of the IMP is unknown within 1 month.

• Pregnant, breast-feeding, or planning to conceive or father a child within twelve weeks of cessation of treatment for males and within one week of cessation of treatment for females.

• Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes

• Any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.

• glucocorticoids within one year prior to dosing.

• HIV infection with helper/inducer T lymphocyte (CD4 cell) count of less than or equal to 300x10-6/L.

• Receiving antiretroviral therapy (ART).