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

NCT ID: NCT00859755

Last Updated: 2012-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ARRY-403

Group Type: EXPERIMENTAL

ARRY-403, glucokinase activator; oral

Intervention Type: DRUG

single dose, escalating

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo; oral

Intervention Type: DRUG

matching placebo

Interventions

ARRY-403, glucokinase activator; oral

single dose, escalating

Intervention Type: DRUG

Placebo; oral

matching placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States

Countries

United States

Other Identifiers

ARRAY-403-101

Identifier Type: -

Identifier Source: org_study_id