Tuberculosis
Conditions
Interventions
Product Name: R207910
Product Code: R207910
Pharmaceutical Form: Oral solution
Current Sponsor code: R207910
Concentration unit: % percent
Concentration type: equal
Sponsors
Tibotec Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Clinically significant laboratory abnormalities, significant abnormal physical examination or 12-lead electrocardiogram (ECG) at screening or significant illnesses other than TB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed