A Safety Study of ARRY-300 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00828165
First received: January 22, 2009
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Healthy
Drug: ARRY-300, MEK inhibitor; oral
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. [ Time Frame: Following a single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-300 Drug: ARRY-300, MEK inhibitor; oral
single dose, escalating
Placebo Comparator: Placebo
Placebo
Drug: Placebo
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828165

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

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00828165     History of Changes
Other Study ID Numbers: ARRAY-300-101
Study First Received: January 22, 2009
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014