A Safety Study of ARRY-300 in Healthy Subjects

NCT00828165 | Completed Phase 1

• 1 other identifier: ARRAY-300-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.

  Duration of study

Study Arms (2)

ARRY-300

EXPERIMENTAL

Drug: ARRY-300, MEK inhibitor; oral

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ARRY-300, MEK inhibitor; oral DRUG

single dose, escalating

ARRY-300

Placebo DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

US (1)