A Safety Study of ARRY-300 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
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.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ARRY-300, MEK inhibitor; oral
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive. Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight > 50 kg (110 lbs) and < 113 kg (280 lbs). Additional criteria exist. Key Exclusion Criteria: Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). A condition possibly affecting drug absorption (e.g., gastrectomy). Women who are pregnant or breastfeeding. A positive test for drugs or alcohol. Use of tobacco- or nicotine-containing products in excess of 5 cigarettes per day, or daily use of pipe, cigar, chewing tobacco or nicotine gum or patches. Treatment with an investigational drug within 30 days prior to first dose of study drug. Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to the first dose of study drug. As exceptions, acetaminophen may be used at doses of ≤ 1 g/day or ibuprofen may be used at doses of ≤ 800 mg/day until 24 hours prior to first dose of study drug. Blood donation of ≥ 1 pint within 30 days prior to first dose of study drug. Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing. Additional criteria exist.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-300<br> | Drug: ARRY-300, MEK inhibitor; oral<br>* single dose, escalating<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. |  | Duration of study |