A Safety Study of ARRY-502 in Healthy Subjects
This study has been completed.
Information provided by (Responsible Party):
First received: May 5, 2011
Last updated: October 19, 2011
Last verified: October 2011
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.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
Oral; multiple dose, escalating
Placebo Comparator: Placebo
Oral; matching placebo
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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
|Madison, Wisconsin, United States |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 5, 2011
||October 19, 2011
||United States: Food and Drug Administration
Keywords provided by Array BioPharma:
ClinicalTrials.gov processed this record on September 16, 2014