A Safety Study of ARRY-300 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ARRY-300, MEK inhibitor; oral; Drug: Placebo

• Registration Number: NCT00828165
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARRY-300	ARRY-300, MEK inhibitor; oral	-
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.	Duration of study

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States