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

NCT ID: NCT00859755

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

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ARRY-403, glucokinase activator; oral

single dose, escalating

Intervention Type DRUG

Placebo; oral

matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

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Array BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States

Site Status

Countries

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United States

Other Identifiers

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ARRAY-403-101

Identifier Type: -

Identifier Source: org_study_id