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: NCT00859755
• Other study ID #: ARRAY-403-101
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2009
• Last updated: August 29, 2012
• Start date: March 2009

Study information

• Verified date: August 2012
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research, Inc.	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Array BioPharma

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	Yes
Primary	Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.		Day 1, Day 2	No
Secondary	Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.		Day 1, Day 2	No
Secondary	Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge.		Day 1, Day 2	No
Secondary	Assess the excretion of the study drug and metabolites in urine following dosing.		Day 1, Day 2	No