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Multiple Dose Trial of Anti-Glycation Agent GLY-230 in Healthy and Diabetic Subjects

This study has been completed.
Sponsor:
Information provided by:
Glycadia
ClinicalTrials.gov Identifier:
NCT00544934
First received: October 15, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects


Condition Intervention Phase
Diabetic Nephropathy
 Drug: GLY-230
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Dose-Ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glycadia:

Primary Outcome Measures:
  • glycated albumimin concentration [ Time Frame: three weeks ]

Secondary Outcome Measures:
  • urine albumin [ Time Frame: three weeks ]

Enrollment: 42
Study Start Date: February 2007
Study Completion Date: October 2007
Intervention Details:
    Drug: GLY-230
    125, 250 0r 375 mg bid for 14 days
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent

Exclusion Criteria:

  • Sctive concomitant serious medical or surgical disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544934

Sponsors and Collaborators
Glycadia
Investigators
Principal Investigator: Laurence Kennedy, M.D. University of Florida
Principal Investigator: Maria del Pilar Solano, M.D. University of Miami, Miami, Florida
Principal Investigator: Lis Cohen, D.O. Suncoast Clinical Research, New Port Richey, Florida
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00544934     History of Changes
Other Study ID Numbers: GLY-002
Study First Received: October 15, 2007
Last Updated: October 15, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013