Participants.
SAD
In part 1 of the phase I study (SAD study), 48 healthy adult males were screened and subsequently enrolled. All participants completed the trial. In part 2 (food effects study), 12 healthy adult males were screened and subsequently enrolled. One of 6 (16.7%) participants discontinued early in the standard, then fasted, then high-fat group (1 consent withdrawal during period 1). Two of 6 (33.3%) participants discontinued early in the fasted, then high-fat, then standard meal group (1 consent withdrawal in period 1, and 1 positive urine drug screen in period 2). All other participants in the two treatment sequences completed the trial. Demographic and baseline characteristics were generally similar across dose cohorts in the SAD study (see Table S1 in the supplemental material) and across the two treatment sequences in the food effects study (Table S2).In the MAD/EBA study, 76 HIV-negative adults with smear-positive, rifampicin- and isoniazid-susceptible pulmonary TB were enrolled. Of these, 59 received OPC-167832 (3 mg [Demographic and baseline bacterial characteristics (sputum CFU/mL, sputum LAM concentrations, and MGIT-TTD) were comparable across the dosing cohorts in the MAD/EBA study (Table S3). Mean baseline log