Status:
COMPLETED
A Safety Study of ARRY-300 in Healthy Subjects
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 ...
Eligibility Criteria
Inclusion
- Key
- Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive.
- Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight \> 50 kg (110 lbs) and \< 113 kg (280 lbs).
- Additional criteria exist.
- Key
Exclusion
- Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- A condition possibly affecting drug absorption (e.g., gastrectomy).
- Women who are pregnant or breastfeeding.
- A positive test for drugs or alcohol.
- Use of tobacco- or nicotine-containing products in excess of 5 cigarettes per day, or daily use of pipe, cigar, chewing tobacco or nicotine gum or patches.
- Treatment with an investigational drug within 30 days prior to first dose of study drug.
- Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to the first dose of study drug. As exceptions, acetaminophen may be used at doses of ≤ 1 g/day or ibuprofen may be used at doses of ≤ 800 mg/day until 24 hours prior to first dose of study drug.
- Blood donation of ≥ 1 pint within 30 days prior to first dose of study drug.
- Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
- Additional criteria exist.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00828165
Start Date
January 1 2009
End Date
April 1 2009
Last Update
October 6 2020
Active Locations (1)
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1
PPD Development, LP
Austin, Texas, United States, 78744