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

NCT00859755 | Completed Phase 1

• 1 other identifier: ARRAY-403-101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.

  Duration of study

• Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.

  Day 1, Day 2

Secondary Outcomes (3)

• Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.

  Day 1, Day 2

• 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

• Assess the excretion of the study drug and metabolites in urine following dosing.

  Day 1, Day 2

Study Arms (2)

ARRY-403

EXPERIMENTAL

Drug: ARRY-403, glucokinase activator; oral

Placebo

PLACEBO COMPARATOR

Drug: Placebo; oral

Interventions

ARRY-403, glucokinase activator; oral DRUG

single dose, escalating

ARRY-403

Placebo; oral DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array BioPharma: lead

Study Sites (1)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ARRY-403

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

US (1)