Table 3.
Summary of phase I clinical trials with WX-671
Study | Study title |
---|---|
Phase I: monotherapy | ‘An open label phase I study to investigate the bioavailability and pharmacokinetics of oral WX-671 given at three dose levels pre- and post-prandially to healthy male subjects (WX/60–001)’ |
Phase I: monotherapy | ‘A randomized, double blind, placebo controlled phase I study designed to evaluate the tolerability and pharmacokinetic (PK) profile of three multi-dose regimens of oral WX-671 in healthy male subjects (WX/60–002)’ |
Phase lb: monotherapy | ‘Phase I study to investigate the pharmacokinetics, safety and tolerability of multiple oral doses of the serine protease inhibitor WX-671 in patients with advanced head and neck carcinoma (WX/60–003)’ |
Phase I: monotherapy | ‘14C-WX-671 – a phase I, open label study of absolute bioavailability, metabolism, and excretion following a single oral dose to healthy male subjects (WX/60–005)’ |