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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

Summary

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

Conditions

Solid Tumors

Intervention

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

Location

Premiere Oncology
Santa Monica
California
United States
90404

Status

Not yet recruiting

Source

Daiichi Sankyo Inc.

Results (where available)

View Results

Links

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

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