Overview
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
Status:
Completed
Completed
Trial end date:
2018-11-08
2018-11-08
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207 and its primary metabolite M2.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Pharmaceutical K.K.Treatments:
Bedaquiline
Diarylquinolines
Criteria
Inclusion Criteria:- Must have confirmed pulmonary multi-drug resistant tuberculosis (MDR-TB) infection,
which is defined as infection by a strain of M. tuberculosis resistant to both
rifampicin and isoniazid (RFP and INH) by previous screening from a TB treatment
- Must have confirmed positive results for acid-fast bacilli (AFB) on direct smear
examination of expectorated sputum specimen (more than [>] 1+ smear-positive) during
the Screening Phase or sputum culture positive for M. tuberculosis within the
preceding 3 months
- A women must not be of childbearing potential: postmenopausal or permanently
sterilized or otherwise be incapable of pregnancy, or if childbearing potential and
practicing a highly effective method of birth control consistent with local
regulations regarding the use of birth control methods and a man who is sexually
active with a woman of childbearing potential and has not had a vasectomy must agree
to use a barrier method of birth control
- Must be willing and able to adhere to the prohibitions and restrictions specified in
this protocol
- Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of and procedures required for the study and are willing to participate in the
study
Exclusion Criteria:
- Has 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 or otherwise make the subject a poor
candidate for a clinical study
- Has complicated or severe extra-pulmonary manifestations of TB, including central
nervous system infection
- Participants with significant cardiac arrhythmia requiring medication
- Participants with the abnormal electrocardiogram (ECG) parameters as defined in
protocol
- Has human immuno deficiency virus (HIV) antibody positive during the Screening Phase