A phase I study in healthy adults was conducted to assess the pharmacokinetic, safety, and tolerability profiles of single ascending doses of OPC-167832, as well as the effects of food on its absorption, distribution, and elimination. This phase I study was followed by a phase I/IIa study, in which adult participants with drug-susceptible pulmonary TB were treated for 14 days with ascending doses of OPC-167832 monotherapy. The latter trial was designed to assess not only the pharmacokinetic, safety, and tolerability profiles of OPC-167832, but also to provide preliminary data on early bactericidal activity (EBA) in a clinical setting.
The study was completed in March 2022, with results published in June 2023. OPC-167832 was well tolerated at single ascending doses (10 to 480 mg) in healthy participants and multiple ascending doses (3 to 90 mg) in participants with TB. In both populations, nearly all treatment-related adverse events were mild and self-limiting, with headache and pruritus being the most common events.
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