Trial record 1 of 2 for:
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.
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 April 23, 2014