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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952198
• Other study ID #: ARRAY-403-102
• Status: Completed
• Phase: Phase 1
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• ARRY-403, glucokinase activator; oral
multiple dose, escalating
• Placebo; oral
matching placebo

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research	Chula Vista	California
United States	Cetero	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.		Duration of study
Primary	Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.		10 days
Secondary	Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT).		10 days
Secondary	Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.		10 days