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 (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 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), 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.
Sites / Locations
- Profil Institute for Clinical Research
- Cetero
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
Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT).
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Full Information
NCT ID
NCT00952198
First Posted
August 4, 2009
Last Updated
October 2, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00952198
Brief Title
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 with Type 2 diabetes. Approximately 128 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
128 (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
multiple 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
10 days
Secondary Outcome Measure Information:
Title
Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT).
Time Frame
10 days
Title
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 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), 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute for Clinical Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Cetero
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
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