Status:
COMPLETED
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Lead Sponsor:
Array BioPharma
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36 patients from the US wil...
Eligibility Criteria
Inclusion
- Key
- Male or female with willingness and ability to use protocol-specified methods of contraception, except females of nonchildbearing potential.
- Diagnosis of Type 2 diabetes less than 5 years prior to study start.
- HbA1c ≥ 6.5% and ≤ 10%.
- BMI ≥ 25 and ≤ 40.0 kg/m2.
- Additional criteria exist.
- Key
Exclusion
- Recent history (i.e., less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, 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).
- Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia.
- History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
- Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed.
- A positive test for drugs or alcohol.
- Women who are pregnant or breastfeeding.
- Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug.
- Additional criteria exist.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00859755
Start Date
March 1 2009
Last Update
August 30 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911