clinical trial · NCT03678688
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
Otsuka Pharmaceutical Development & Commercialization, Inc.·phase2·completed·n = 122
Pulmonary TB10 mg OPC-16783230 mg OPC-16783290 mg OPC-1678323 mg OPC-167832RHEZ30 mg OPC-167832 + 300 mg delamanid30 mg OPC-167832 + 400 mg BDQ30 mg OPC-167832 + 300 mg delamanid + 400 mg BDQ
brief 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).
started
Oct 18, 2018
primary completion
Feb 14, 2022
completion
Mar 11, 2022
last updated
Nov 18, 2023
official title
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
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