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A Safety Study of ARRY-502 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01349725
First received: May 5, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.


Condition Intervention Phase
Healthy
Drug: ARRY-502
Drug: Placebo
Phase 1

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

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the pharmacodynamics of the study drug as determined by laboratory assays. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-502 Drug: ARRY-502
Oral; multiple dose, escalating
Placebo Comparator: Placebo Drug: Placebo
Oral; 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 between the ages of 18 and 50 years.
  • Females must be of nonchildbearing potential.
  • Body mass index (BMI) of 18 to 32 and a total body weight > 50 kg (110 lbs) and < 114 kg (250 lbs).
  • Additional criteria exist.

Key Exclusion Criteria:

  • Evidence or history of clinically significant disease (excepting allergic rhinitis).
  • Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  • Gastrointestinal surgery that may interfere with motility or absorption.
  • Serious illness requiring hospitalization within the previous 6 months.
  • A positive test for drugs or alcohol.
  • Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days.
  • Use of corticosteroids within the previous 28 days.
  • Recent history of blood, plasma or platelet donation.
  • Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months.
  • Prior exposure to investigational study drug ARRY-502.
  • 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: NCT01349725

Locations
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01349725     History of Changes
Other Study ID Numbers: ARRAY-502-102
Study First Received: May 5, 2011
Last Updated: October 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Array BioPharma:
Safety

ClinicalTrials.gov processed this record on August 26, 2014