Phase I Single Ascending Dose and Food Effect Study in Healthy Adults and Phase I/IIa Multiple Ascending Dose Study in Patients with Pulmonary Tuberculosis to Assess Pharmacokinetics, Bactericidal Activity, Tolerability, and Safety of OPC-167832
Rodney Dawson, Andreas H. Diacon, Kim Narunsky, Veronique de Jager, Kelly Wallace Stinson, Xiaoyan Zhang, Yongge Liu, Jeffrey Hafkin
Abstract
OPC-167832, an inhibitor of decaprenylphosphoryl-β- d -ribose 2’-oxidase, demonstrated potent antituberculosis activity and a favorable safety profile in preclinical studies. This report describes the first two clinical studies of OPC-167832: (i) a phase I single ascending dose (SAD) and food effects study in healthy participants; and (ii) a 14-day phase I/IIa multiple ascending dose (MAD; 3/10/30/90 mg QD) and early bactericidal activity (EBA) trial in participants with drug-susceptible pulmonary tuberculosis (TB).
Topics & Concepts
PharmacokineticsTolerabilityMedicineCmaxAdverse effectArea under the curvePharmacologyInternal medicineMinimum inhibitory concentrationGastroenterologyAntibioticsChemistryBiochemistryTuberculosis Research and EpidemiologyAntibiotics Pharmacokinetics and EfficacyCancer therapeutics and mechanisms