NCT03678688

A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary TB

Interventions

Type	Name	Description
DRUG	10 mg OPC-167832	Once daily oral dose of 10 mg OPC-167832 from Day 1 through Day 14.
DRUG	30 mg OPC-167832	Once daily oral dose of 30 mg OPC-167832 from Day 1 through Day 14.
DRUG	90 mg OPC-167832	Once daily oral dose of 90 mg OPC-167832 from Day 1 through Day 14.
DRUG	3 mg OPC-167832	Once daily oral dose of 3 mg OPC-167832 from Day 1 through Day 14.
DRUG	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
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2018-10-18
• Primary completion: 2022-02-14
• Completion: 2022-03-11
• First posted: 2018-09-20
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

3 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study