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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.
ClinicalTrials.gov Identifier: NCT00828165
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ARRY-300, MEK inhibitor; oral Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Study Start Date : January 2009
Primary Completion Date : April 2009
Study Completion Date : April 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: ARRY-300 Drug: ARRY-300, MEK inhibitor; oral
single dose, escalating
Placebo Comparator: Placebo
Placebo
Drug: Placebo
matching placebo


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. [ Time Frame: Following a single dose ]

Secondary Outcome Measures :
  1. Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [ Time Frame: Duration of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828165


Locations
United States, Texas
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Array BioPharma
More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00828165     History of Changes
Other Study ID Numbers: ARRAY-300-101
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012