- Subject has consumed or will consume any concomitant therapy; prescription or over-the-counter (OTC) medication; or nutritional, herbal, or vitamin supplements other than contraceptives (eg, oral, systemic) and ibuprofen (only if needed, maximum 2.4 g/day) from 14 days or 5 half-lives (whichever is longer) before dosing and while confined to the CRU