Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial.

Abstract

A Phase 1, open-label, single-dose, fixed-sequence crossover study utilizing a hybrid decentralized clinical trial (DCT) design with and without practice sessions for wearable devices and PK sampling was conducted in eight healthy participants. Using etrasimod, the study assessed the feasibility of conducting a Phase 1 hybrid DCT by the Pfizer Clinical Research Unit (PCRU) staff, involving remote collection of pharmacokinetic (PK), safety, and tolerability data. The study objectives were to determine the PK and to assess the safety and tolerability of etrasimod clinical immediate release tablets in healthy adult participants in a hybrid DCT design. The study consisted of two periods, and the treatments were administered to participants in a fixed sequence: a single oral dose of etrasimod, then DCT with practice sessions in Period 1, followed by a single oral dose of etrasimod and DCT without practice sessions in Period 2. PK results were compared between Periods 1 and 2, and vs. PK from a single oral dose of etrasimod administered on site in a previous conventional design study. Serum etrasimod exposure was similar for non-practice vs. practice sessions within the hybrid DCT framework. PK parameters data from self-collected microsamples in the hybrid DCT design were comparable to PK parameters data from venous samples collected in a conventional setting. The wearable monitoring devices for recording the electrocardiogram (ECG) and vital parameters allowed remote and real-time assessment of safety and tolerability. Therefore, the study results demonstrated the feasibility of using multiple DCT modalities in Phase 1 trials for remote PK, safety, and tolerability assessments.