TMC207
Sponsors
Janssen Infectious Diseases BVBA, Tibotec BVBA, National Institute of Allergy and Infectious Diseases (NIAID), Global Alliance for TB Drug Development
Conditions
HIVHealthy VolunteerModerate Hepatic ImpairmentPulmonary TuberculosisTuberculosis
Phase 1
TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer
CompletedNCT00828529
Start: 2009-02-28End: 2009-05-31Updated: 2012-08-15
Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers
CompletedNCT00992069
Start: 2009-12-31End: 2010-12-31Updated: 2021-11-01
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
CompletedNCT01012284
Start: 2010-01-31End: 2011-01-31Updated: 2012-12-20
TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions
CompletedNCT01291563
Start: 2011-02-28End: 2011-04-30Updated: 2012-11-06
TMC207 +/- Rifabutin/Rifampin
CompletedNCT01341184
Start: 2011-10-21End: 2012-05-23Updated: 2017-04-21
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
CompletedNCT02216331
Start: 2010-03-31End: 2010-05-31Updated: 2019-09-06
Phase 2
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
CompletedNCT00449644
Start: 2007-06-30End: 2012-10-31Updated: 2014-04-29
TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
CompletedNCT00523926
Start: 2005-05-31End: 2005-10-31Updated: 2012-08-15
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.
CompletedNCT00910871
Start: 2009-09-30End: 2013-01-31Updated: 2015-04-24
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
CompletedNCT01215110
Start: 2010-04-30End: 2010-09-30Updated: 2017-04-26
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
CompletedNCT01215851
Start: 2010-10-31End: 2011-08-31Updated: 2017-02-28