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Clinical Research Coordinator Analysis

Cycle 1 Day 1/Day 2 Pharmacokinetic (PK) Sample Collection Logistics

Finding: The protocol (Section 6.4.1.2 and Table 6-1, SoA) mandates an intensive PK sampling schedule on Cycle 1 Day 1 (C1D1), with samples required up to 10 hours post-dose, followed by a 24-hour post-dose sample on Cycle 1 Day 2 (C1D2). This poses a significant logistical challenge for site staff, potentially requiring extended clinic hours or split shifts, and creates a considerable burden for participants due to the long duration on C1D1 and the need to return for the C1D2 sample. The protocol lacks explicit guidance on managing potential overnight stays for participants or the precise flexibility (e.g., window) for the 24-hour PK sample if an overnight stay is not feasible or planned. Recommendation: We recommend requesting clarification from the Sponsor regarding:

1. Whether overnight stays for participants between C1D1 and C1D2 are permissible, budgeted, or expected, and if so, what site provisions (e.g., inpatient bed, hotel) are considered acceptable.

2. If overnight stays are not standard or feasible for all participants/sites, to provide a clearly defined and operationally practical collection window for the 24-hour PK sample (e.g., 24 ± 2 hours post C1D1 dose administration) to better accommodate participant travel and standard site clinic operating hours, while ensuring the window does not compromise data integrity.

3. Consider providing sites with best practice examples or suggestions for staffing models to adequately cover the extended C1D1 visit duration and ensure all PK samples are collected per protocol.

Rationale: Clarifying these logistical aspects proactively will enable sites to plan staffing and resources more effectively, enhance participant recruitment and retention by minimizing burden, reduce the risk of missed PK samples or protocol deviations related to sample timing, and ultimately ensure consistent and high-quality data collection across all participating sites.