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

Array BioPharma

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo; oral

Drug: ARRY-403, glucokinase activator; oral

Study type

Interventional

Funder types

Industry

Identifiers

NCT00859755

ARRAY-403-101

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.