At a glance
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A Phase 1/2, Active-controlled, Randomized, Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Oral Doses of OPC-167832 Tablets in Subjects With Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating 10 mg OPC-167832, 30 mg OPC-167832, and 6 other interventions for Pulmonary TB. Completed, enrolled 122 participants across 3 sites.
Detailed Summary
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
Study Details
Timeline
Interventions
Once daily oral dose of 10 mg OPC-167832 from Day 1 through Day 14.
Once daily oral dose of 30 mg OPC-167832 from Day 1 through Day 14.
Once daily oral dose of 90 mg OPC-167832 from Day 1 through Day 14.
Once daily oral dose of 3 mg OPC-167832 from Day 1 through Day 14.
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
Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid from Day 1 through Day 14.
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.
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.