PK/PD Sampling During Dose Modification Clause Samples

PK/PD Sampling During Dose Modification. ‌ Intensive PK/PD sampling may be performed, if feasible, without food restrictions. All patients will have a Week 4 (Day 28) and a Week 28 (Day 196) intensive PK sampling regardless of whether their dose has been escalated (see Table 2). Sites should collect as many samples as possible during the 12-hour period, with the last sample collected being a PK/PD sample before the patient leaves the site. For sites that cannot perform the intensive PK/PD sampling, a predose and a 2.5-hour postdose sample will be acceptable. Samples for PK/PD and safety laboratory assessments should be performed at the next in-clinic visit and not sooner than 4 days after the dose escalation (refer to Table 2) since it will take at least 4 days to achieve steady-state conditions. Patients who have been dose escalated may be dose reduced to a lower dose for safety or tolerability reasons following consultation between the Investigator and the Sponsor’s Medical Monitor.