Tuberculosis
Conditions
Interventions
Product Name: TMC207
Product Code: TMC207 (F004)
Pharmaceutical Form: Oral solution
Current Sponsor code: TMC207
Other descriptive name: R207910
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Tibotec Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female. Females may participate if they are of non-childbearing potential or using effective non-hormonal birth control methods and willing to continue practicing these birth control methods for at least 14 days after the end of the study period. 2. Aged between 18 and 65 years, extremes included 3. Treatment-naïve subjects (or subjects who have not received treatment in the last 3 years) with sputum smear-positive pulmonary tuberculosis willing to start anti-TB therapy 4. Adequate sputum specimens (at least 15 mL/day), as estimated from a spot specimen collected prior to admission 5. Positive for acid-fast bacilli on direct spear examination of sputum specimen (i.e., =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to the study medications (including any rifamycin antibiothics) 2. Current or past history of alcohol and/or drug use that, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures 3. History or presence of hepatic or gastrointestinal disease that might, in the judgment of the investigator, interfere with the absorption, distribution, metabolism or elimination of TMC207, rifampin, isoniazid, or pyrazinamide 4. A concomitant infection that requires and additional systemic antimicrobial agent 5. Subjects who have received any previous anti-mycobacterial drugs for the treatment of atypical mycobacterial infection or leprosy and subjects who have received more that 2 weeks of antibiotic treatment with a fluoroquinone drug (such as ciprofloxacin, ofloxacin, moxifloxacin) 6. Subjects who have received antiretroviral therapy and/or oral or intravous antifungal medication within the last 90 days and/or subjects, for whom in the opinion of the ivnestigator, early antiretroviral therapy is indicated 7. Presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult 8. Impaired hepatic function, as shown by the following: - Aspartate aminotransferase (AST)> 2.5 times the upper limit of normal (ULN) - Alanine aminotransferase (ALT)> 2.5 times ULN - Alkaline phosphatase (ALP)>2 times ULN - Total bilirubin>2.5 times ULN 9. Subjects how have received any other investigational medication within 30 days prior to study entry 10. Participation in other drug studies within 3 months (except for Brazil: within 12 months) prior to study initiation 11. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 12. Unlikely to comply with the protoocl, e.g., uncooperative attitude, inability to remain hospitalized and unlikelihood of completing the study 13. Women how are pregnant and/or breast feeding 14. Previous participation in an investigational drug trial within TMC207.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects at 14 days of treatment of multiple oral doses of TMC207 combined with isoniazid (JH), combined with pyrazinamide (JZ), combined with rifampin (JR) and combined with isoniazid and pyrazinamide (JHZ), on M. tuberculosis sputum viable count in treatment-naïve subjects with sputum smear-positive pulmonary tuberculosis compared to the 3 principle drugs of standard anti-TB therapy (HRZ). ;Secondary Objective: To assess short-term safety and tolerability as well as plasma through concentrations of multiple oral doses of TMC207 when administered in combination with isoniazid (JH), with pyrazinamide (JZ), with rifampin (JR), or in combination with isoniazid and pyrazinamide (JHZ) in treatment-naïve subjects with sputum smear-positive pulmonary tuberculosis. ;Primary end point(s): To assess extended early bactericidal activity (eEBA) of TMC207 combined with isoniazid (JH), with pyrazinamide (JZ), with rifampin (JR) or with both isoniazid and and pyrazinamide (JHZ) to allow recommendations for treatment combinations for future clinical trials. | — |
Countries
United Kingdom
Outcome results
None listed