An open label study to evaluate the effects on Mycobacterium tuberculosis, safety, tolerability and pharmacokinetics of single doses of R207910, in treatment naive patients with mycobacterium tuberculosis infection. - BAC2001
Phase 1
- Conditions
- Tuberculosis
- Registration Number
- EUCTR2004-002202-30-GB
- Lead Sponsor
- Tibotec Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Population will comprise of male and female, who are post menopausal or surgically sterilized, patient volunteers aged 18-65 years who have been diagnossed as having open pulmonary M. tuberculosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Clinically significant laboratory abnormalities, significant abnormal physical examination or 12-lead electrocardiogram (ECG) at screening or significant illnesses other than TB
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of single oral doses of R207910 on M. tuberculosis sputum viable count in treatment of naive patients with pulmonary M. tuberculosis infection.;Secondary Objective: To assess the safety, tolerability, and pharmacokinetics of single oral doses of R207910 in treatment naive patients with pulmonary M. tuberculosis infection.;Primary end point(s): Assess the effects of R207910 on M. tuberculosis sputum viable count
- Secondary Outcome Measures
Name Time Method