A Safety Study of ARRY-300 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828165
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : August 30, 2012
Information provided by (Responsible Party):
Array BioPharma

January 22, 2009
January 23, 2009
August 30, 2012
January 2009
April 2009   (Final data collection date for primary outcome measure)
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: Duration of study ]
  • Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. [ Time Frame: Following a single dose ]
  • Adverse Events [ Time Frame: Screening - Follow-up ]
  • Findings on physical examination and clinical laboratory abnormalities [ Time Frame: Day 1 - Follow-up ]
  • Change in vital sign measurements [ Time Frame: Day 1 - Follow-up ]
  • Change in 12-lead electrocardiogram (ECG) parameters [ Time Frame: Day 1 - Follow-up ]
  • Plasma concentrations of ARRY-300 and a sulfoxide metabolite [ Time Frame: Following a single dose ]
Complete list of historical versions of study NCT00828165 on Archive Site
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [ Time Frame: Duration of study ]
Characterization of the pharmacodynamic (PD) activity of ARRY-300 on biomarkers in whole blood after a single oral dose. The percent of pre-initial-dose levels of these cytokines will be correlated with plasma concentrations. [ Time Frame: Duration of study ]
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A Safety Study of ARRY-300 in Healthy Subjects
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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.
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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
  • Drug: ARRY-300, MEK inhibitor; oral
    single dose, escalating
  • Drug: Placebo
    matching placebo
  • Experimental: ARRY-300
    Intervention: Drug: ARRY-300, MEK inhibitor; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Array BioPharma
Array BioPharma
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Array BioPharma
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP