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.

A Phase IIa, Open Label Study to Determine the Early Bactericidal,Extended Early Bactericidal Activity and Pharmacokinetic Study of LL 3858 of Lupin Limited for the Treatment of Newly Diagnosed Sputum Smear-Positive Pulmonary Tuberculosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000741

Enrollment

Registered

2009-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Oral Tablets Of LL 3858: 400mg of LL 3858 OD for 5 days Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr.Anil Avhad

rajeshkumawat@lupinpharma.com+91-20-66749400

Outcome results