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

NCT00952198 | Completed Phase 1

• 1 other identifier: ARRAY-403-102
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients with Type 2 diabetes. Approximately 128 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.

  10 days

Secondary Outcomes (2)

• Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT).

  10 days

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

  10 days

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

multiple dose, escalating

ARRY-403

Placebo; oral DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (females must be of non-childbearing potential), between the ages of 18 and 70 years, inclusive.
• Diagnosis of Type 2 diabetes.
• Fasted C-peptide value ≥ 0.8 ng/mL.
• HbA1c ≥ 6.5% and ≤ 10.0% for monotherapy cohorts (study drug only) or HbA1c ≥ 7.5% and ≤ 10.0% for combination cohorts (study drug and on a stable regimen of metformin monotherapy that includes a morning dose for ≥ 8 weeks prior to first dose of study drug).
• BMI ≥ 25.0 kg/m2 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), or other conditions at the discretion of the investigator.
• 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.
• A positive test for drugs or alcohol.
• 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.
• 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, now a wholly owned subsidiary of Pfizer: lead

Study Sites (2)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

Cetero

San Antonio, Texas, 78229, 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 Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: August 4, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

US (2)