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| Sponsored by: |
Synvista Therapeutics, Inc |
|---|---|
| Information provided by: | Synvista Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00491543 |
Purpose
ALT-2074 (BXT-51072) belongs to a class of drugs called "glutathione peroxidase mimics." ALT-2074 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2 genotype have poor cardiovascular clinical outcomes.
The purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Coronary Artery Disease |
Drug: ALT-2074 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ALT 2074 in Subjects With Type 2 Diabetes Who Have a Haptoglobin Type 2-2 Genotype and Coronary Artery Disease |
| Estimated Enrollment: | 66 |
| Study Start Date: | June 2007 |
| Study Completion Date: | May 2008 |
Subjects will be male and female, 18 to 75 years old, with Type 2 diabetes mellitus, a documented or suspected history of coronary artery disease, and a Haptoglobin type 2-2 (Hp 2-2) genotype. Subjects on prescribed anti-diabetic and coronary artery disease medications may continue to take their medications throughout the study.
Subjects who qualify will receive active drug (ALT-2074 20 mg, 40 mg or 80 mg) or placebo every 8 hours for 28 days. There will be three sequential cohorts of increasing doses of active drug. There will be 2 follow-up visits (Days 35 and 42). Blood and urine tests for safety (chemistry and hematology), pharmacokinetics and relevant biomarkers to measure inflammation and oxidative stress will be performed throughout the study.
Electrocardiograms and 24-hour Holter monitoring will also be performed at various time points during the study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Ability to communicate and comply with all study requirements.
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Contacts and Locations| United States, Illinois | |
| Radiant Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Ohio | |
| Radiant Research | |
| Cincinnati, Ohio, United States, 45249 | |
| Principal Investigator: | Jeffrey G Geohas, MD | Radiant Research |
| Principal Investigator: | Michale Noss, MD | Radiant Reasearch |
More Information
| Study ID Numbers: | ALT-2074-201 |
| Study First Received: | June 23, 2007 |
| Last Updated: | July 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00491543 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Ischemia |
Arteriosclerosis Coronary Disease Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Coronary Artery Disease |
|
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Arteriosclerosis Coronary Disease Diabetes Mellitus, Type 2 Cardiovascular Diseases Glucose Metabolism Disorders Coronary Artery Disease |
