122
Participants
Start Date
October 18, 2018
Primary Completion Date
February 14, 2022
Study Completion Date
March 11, 2022
10 mg OPC-167832
Once daily oral dose of 10 mg OPC-167832 from Day 1 through Day 14.
30 mg OPC-167832
Once daily oral dose of 30 mg OPC-167832 from Day 1 through Day 14.
90 mg OPC-167832
Once daily oral dose of 90 mg OPC-167832 from Day 1 through Day 14.
3 mg OPC-167832
Once daily oral dose of 3 mg OPC-167832 from Day 1 through Day 14.
RHEZ
"RHEZ was used in both Stage 1 and Stage 2. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol. Participants received a single-dose from Day 1 through Day 20. The total number of tablets per day was based on the pretreatment body weight:~* Participants weighing 30 to 37 kg received 2 tablets per day~* Participants weighing 38 to 54 kg received 3 tablets per day~* Participants weighing 55 to 70 kg received 4 tablets per day~* Participants weighing \> 70 kg received 5 tablets per day"
30 mg OPC-167832 + 300 mg delamanid
Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid from Day 1 through Day 14.
30 mg OPC-167832 + 400 mg BDQ
Once daily oral dose of 30 mg OPC-167832 plus 400 mg BDQ from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ was 400 mg QD for Days 3 to 14.
30 mg OPC-167832 + 300 mg delamanid + 400 mg BDQ
Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid plus 400 mg BDQ from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ was 400 mg QD for Days 3 to 14.
Satellite Site: Task at Brooklyn Chest Hospital, Cape Town
TASK Clinical Research Centre, Cape Town
University of Cape Town (Pty) Ltd., Cape Town
Bill and Melinda Gates Foundation
OTHER
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY