75
Participants
Start Date
May 6, 2021
Primary Completion Date
September 30, 2022
Study Completion Date
September 30, 2022
Sutezolid
Sutezolid is not licensed yet. Current experience in humans up to Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin
These three licensed drugs form the backbone of a new regimen to which sutezolid is added in arms 2-5.
Midazolam oral solution
Midazolam will be administered as per probe drug use in a single dose of 2 mg at day -1 and day 14 to assess the potential of sutezolid for CYP 459 3A4 enzyme induction, as measured by its influence on the ratio of AUCs of the CYP 3A4 probe drug
The Aurum Institute for Health Research, Johannesburg
Kilimanjaro Clinical Research Institute, Moshi
Ifakara Health Institute, Bagamoyo
National Institute for Medical Research (NIMR - MMRC), Mbeya
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Sequella, Inc.
INDUSTRY
Radboud University Medical Center
OTHER
University of California, San Francisco
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
Michael Hoelscher
OTHER