Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors

2014-07-23 21:08:42 | BioPortfolio


This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Solid Tumors


ARQ 197 Capsule, ARQ 197 Tablet, ARQ 197 Capsule D, oral


Premiere Oncology
Santa Monica
United States


Not yet recruiting


Daiichi Sankyo Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:08:42-0400

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