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
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 April 16, 2014