A phase II a clinical trial for a novel molecule (LL 3858) developed by Lupin Limited which has the potential of treating the Pulmonary tuberculosis patients effectively.
- Registration Number
- CTRI/2009/091/000741
- Lead Sponsor
- upin Limited(Research Park),46A/47A, Nande Village, Mulshi-Taluka,Pune-411042,Maharashtra(India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1Newly diagnosed, previously untreated patients with pulmonary tuberculosis who
have atleast 2 sputum smear positive by fluorescent microscopy.
2 Male patients of 18 to 55 years of age.
3 Body weight of 35-60 kg.
4 Willing to stay in the hospital during the study.
5 Willing to sign Informed Consent.
1 Clinical evidence of Tuberculosis of the Central Nervous System or other extra
pulmonary forms of tuberculosis (However patients with concomitant lymphnode
tuberculosis can be enrolled)
2 Female patients.
3 Concurrent nontuberculous pneumonia.
4 Presence of QTc prolongation (greater than 450 msec) on the baseline ECG
5 Having other serious complicating diseases,for e.g. diabetes mellitus,
hypertension, peptic ulcer disease, epilepsy & leprosy.
6 Those unable to produce an adequate volume of sputum (5ml or more in 16
hours).
7 Patients who are too ill to tolerate a seven days delay in standard therapy.
8 Evidence of abnormal hepatic & renal function.
-Serum bilirubin > 1.2 mg/dl
- AST and ALT are > 2 times the upper limit of normal
-AST or ALT is > 4 times the upper limit of normal
-Blood urea or serum creatinine above the upper limit of normal (43 and 1.3 mg/dl
respectively)
9 Patients with raised Creatinine Phosphokinase levels (>200 U/L).
10 Patients positive for disease markers of Hepatitis B virus, Hepatitis C virus
11 Alcohol or drug dependence/abuse
12 HIV positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety and fall in log10 colony forming units (CFU) of Mycobacterium tuberculosis per ml sputum per day viz.0-2 days (EBA study) and 2-5 days (Extended EBA)Timepoint: Sputum samples(16 hour collection) will be collected before 1st, 3rd, 4th dose and on Day 6
- Secondary Outcome Measures
Name Time Method To determine the Pharmacokinetic profile of 400mg of LL 3858Timepoint: Serial blood samples (2 ml) will be collected at predose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after 1st and 5th dose administration. Blood sample will also be collected on Day 7 (48 hours after last dose) and on Day 8 (72-hours after last dose). Urine Pk 0 to 12 and 12 to 24 hours after first and fifth dose