Bedaquiline Fumarate
- Generic Name
- Bedaquiline Fumarate
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
- First Posted Date
- 2014-08-13
- Last Posted Date
- 2019-09-06
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 32
- Registration Number
- NCT02216331
- Locations
- 🇺🇸
Celerion (MDS Pharma Services), Lincoln, Nebraska, United States
Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
- Conditions
- Tuberculosis
- First Posted Date
- 2011-11-04
- Last Posted Date
- 2017-11-27
- Lead Sponsor
- Janssen Infectious Diseases BVBA
- Registration Number
- NCT01464762
TMC207 +/- Rifabutin/Rifampin
- First Posted Date
- 2011-04-25
- Last Posted Date
- 2017-04-21
- Target Recruit Count
- 33
- Registration Number
- NCT01341184
- Locations
- 🇺🇸
Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine, Cleveland, Ohio, United States
TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- First Posted Date
- 2011-02-08
- Last Posted Date
- 2012-11-06
- Lead Sponsor
- Tibotec BVBA
- Target Recruit Count
- 88
- Registration Number
- NCT01291563
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
Phase 2
Completed
- Conditions
- Pulmonary Tuberculosis
- Interventions
- First Posted Date
- 2010-10-07
- Last Posted Date
- 2017-02-28
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 85
- Registration Number
- NCT01215851
- Locations
- 🇿🇦
Centre for Tuberculosis Research Innovation, UCT Lung Institute, Cape Town, South Africa
🇿🇦Task Applied Science, Karl Bremer Hospital, Cape Town, South Africa
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
- First Posted Date
- 2010-10-06
- Last Posted Date
- 2017-04-26
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 68
- Registration Number
- NCT01215110
- Locations
- 🇿🇦
Karl Bremer Hospital, Belville, Cape Town, South Africa
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
- First Posted Date
- 2009-11-13
- Last Posted Date
- 2012-12-20
- Lead Sponsor
- Tibotec BVBA
- Target Recruit Count
- 16
- Registration Number
- NCT01012284
Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers
- First Posted Date
- 2009-10-08
- Last Posted Date
- 2021-11-01
- Target Recruit Count
- 37
- Registration Number
- NCT00992069
- Locations
- 🇺🇸
Unc Aids Crs, Chapel Hill, North Carolina, United States
🇺🇸Ucsf Aids Crs, San Francisco, California, United States
🇺🇸Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
Phase 2
Completed
- Conditions
- Tuberculosis
- Interventions
- Drug: Background Regimen (BR) for MDR-TB
- First Posted Date
- 2009-06-01
- Last Posted Date
- 2015-04-24
- Lead Sponsor
- Janssen Infectious Diseases BVBA
- Target Recruit Count
- 241
- Registration Number
- NCT00910871
TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer
Phase 1
Completed
- Conditions
- TuberculosisHIV
- First Posted Date
- 2009-01-26
- Last Posted Date
- 2012-08-15
- Lead Sponsor
- Tibotec BVBA
- Target Recruit Count
- 16
- Registration Number
- NCT00828529
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