Back to resultsA Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARRY-403, glucokinase activator; oral
Placebo; oral
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Key Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Profil Institute for Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ARRY-403
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
Secondary Outcome Measures
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge.
Assess the excretion of the study drug and metabolites in urine following dosing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00859755
Brief Title
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array BioPharma
4. Oversight
5. Study Description
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 will be enrolled in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARRY-403
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARRY-403, glucokinase activator; oral
Intervention Description
single dose, escalating
Intervention Type
Drug
Intervention Name(s)
Placebo; oral
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time Frame
Duration of study
Title
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
Time Frame
Day 1, Day 2
Secondary Outcome Measure Information:
Title
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Time Frame
Day 1, Day 2
Title
Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge.
Time Frame
Day 1, Day 2
Title
Assess the excretion of the study drug and metabolites in urine following dosing.
Time Frame
Day 1, Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Profil Institute for Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
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