Overview

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

Status:
Completed

Trial end date:
2011-03-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.

Collaborators:

ArQule
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
ICON Clinical Research