A Safety Study of ARRY-403 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00952198
First received: August 4, 2009
Last updated: August 29, 2012
Last verified: August 2012

August 4, 2009
August 29, 2012
August 2009
August 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • The safety of once-daily (QD) and twice-daily (BID) oral administration of ARRY-403 in patients with type 2 diabetes [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • The PK properties of ARRY-403 and metabolites during QD and BID oral administration of ARRY-403 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952198 on ClinicalTrials.gov Archive Site
  • Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT). [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • The effect of 10 days of QD and BID oral administration of ARRY-403 on glycemic control [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • The PD effects of ARRY-403 during 10 days of QD and BID oral administration on biomarkers, but not limited to, glucose, insulin, C-peptide, glucagon and non-esterified fatty acids [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ARRY-403, glucokinase activator; oral
    multiple dose, escalating
  • Drug: Placebo; oral
    matching placebo
  • Experimental: ARRY-403
    Intervention: Drug: ARRY-403, glucokinase activator; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952198
ARRAY-403-102
No
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP