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A Safety Study of ARRY-502 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01349725
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : October 20, 2011
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: ARRY-502 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: ARRY-502 Drug: ARRY-502
Oral; multiple dose, escalating

Placebo Comparator: Placebo Drug: Placebo
Oral; matching placebo




Primary Outcome Measures :
  1. Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs. [ Time Frame: 3 weeks ]
  2. Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Characterize the pharmacodynamics of the study drug as determined by laboratory assays. [ Time Frame: 2 weeks ]


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 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.

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): NCT01349725


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

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01349725     History of Changes
Other Study ID Numbers: ARRAY-502-102
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by Array BioPharma:
Safety