A Safety Study of ARRY-300 in Healthy Subjects

NCT ID: NCT00828165

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

ARRY-300

Group Type: EXPERIMENTAL

ARRY-300, MEK inhibitor; oral

Intervention Type: DRUG

single dose, escalating

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo

Interventions

ARRY-300, MEK inhibitor; oral

single dose, escalating

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

PPD Development, LP

Austin, Texas, United States

Countries

United States

Other Identifiers

ARRAY-300-101

Identifier Type: -

Identifier Source: org_study_id