Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT03032367
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent, including HIV testing
* Male or female between 18 and 55 years of age inclusive
* Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive
* In the opinion of the investigator, able to comply with the requirements of the protocol e.g. able to attend all visits for PK analysis
* Be of non-childbearing potential or using effective methods of birth control
Exclusion Criteria:
* Known or suspected hypersensitivity or intolerance to bedaquiline or any other constituents of the study drug, i.e. lactose
* A history or clinical evidence of any clinically significant cardiac condition including but not limited to congenital long QT syndrome, Torsades de Pointes, bradyarrhythmias
* Uncontrolled cardiac dysrhythmias
* Severe hepatic impairment (Child Pugh C)
* History, symptoms or signs of heart failure
* History, symptoms or signs of hypothyroidism, whether currently controlled or uncontrolled
* Any other serious uncontrolled medical condition or clinically significant abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
* Evidence of clinically significant (as judged by the investigator), metabolic, gastrointestinal, cardiovascular, musculoskeletal, ophthalmological, pulmonary, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.
* Concomitant use of medicines known to prolong the QTc interval, or use of CYP3A4 inducers/inhibitors including but not limited to, carbamazepine, phenytoin, St. John's wort, ciprofloxacin, erythromycin, clarithromycin, fluconazole, ketoconazole, ritonavir or other anti-retroviral medications, fluoroquinolones and clofazamine.
* HIV positive, already known or as per HIV test done at screening.
* Hepatitis B or C positive
* QTc prolongation as per ECG with a QTcF of \>450msec or any other significant finding on the ECG as per the investigator
* Receipt of any study drug within the past 3 months.
* Scheduled to receive any other investigational drug during the course of the study.
* Known or suspected, current or history of within the past 2 years, alcohol or drug abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the volunteer.
* Evidence or suspicion of active TB or documented recent (within the last year) household contact with an infectious TB case.
* The following toxicities at screening as defined by the DAIDS toxicity table (November 2014)
1. aspartate aminotransferase (AST) grade 3 (≥3.0 x ULN)
2. alanine aminotransferase (ALT) grade 3 (≥3.0 x ULN)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03032367
Study Brief:
Protocol Section:
NCT03032367