A Safety Study of ARRY-300 in Healthy Subjects

NCT00828165 Phase 1 COMPLETED

This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.

Details

Lead sponsor	Array Biopharma, now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2009-01
Completion	2009-04

Conditions

• Healthy

Interventions

• ARRY-300, MEK inhibitor; oral
• Placebo

Primary outcomes

• Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. — Duration of study
• Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. — Following a single dose

Countries

United States