Pharmacokinetics
Plasma pharmacokinetics were assessed for CB-103 via blood samples taken on days 1 (predose, 0.5, 1, 2, 4, 6, 8 hours postdose ± 5 minutes, and 12 hours postdose ± 15 minutes), 2 (24-hour post-day 1, predose), 3 (predose), 8 (predose, 0.5, 1, 2, 4, 6, and 8 hour postdose ± 5 minutes), 9 (24-hour post-day 8, predose), 15, and 22 (predose, and 1 hour postdose) in cycle 1. In cycle 2, on day 1 (predose, 0.5, 1, 2, 6, and, 8 hours postdose ± 5 minutes) and 15 (predose); in cycles 3–6 once at each visit (predose or postdose). For a twice daily dose schedule, pharmacokinetic timepoints were adjusted to evaluate concentration-versus-time curves after morning and evening doses on days 1 and 8.CB-103 concentrations were determined by validated high-performance LC/MS-MS method and analyzed descriptively using Phoenix WinNonlin v6.3 (Pharsight Corporation). Data at timepoints collected were used to generate a population pharmacokinetic model to estimate AUC and C