Status:
COMPLETED
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients wi...
Eligibility Criteria
Inclusion
- Key
- Male or female (females must be of non-childbearing potential), between the ages of 18 and 70 years, inclusive.
- Diagnosis of Type 2 diabetes.
- Fasted C-peptide value ≥ 0.8 ng/mL.
- HbA1c ≥ 6.5% and ≤ 10.0% for monotherapy cohorts (study drug only) or HbA1c ≥ 7.5% and ≤ 10.0% for combination cohorts (study drug and on a stable regimen of metformin monotherapy that includes a morning dose for ≥ 8 weeks prior to first dose of study drug).
- BMI ≥ 25.0 kg/m2 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), or other conditions at the discretion of the investigator.
- 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.
- A positive test for drugs or alcohol.
- 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.
- 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 :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00952198
Start Date
August 1 2009
End Date
August 1 2010
Last Update
October 6 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
2
Cetero
San Antonio, Texas, United States, 78229