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,

SUBMITTER: Malhotra BK 

PROVIDER: S-EPMC12598129 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature