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Phase 1 Study of Anti-Glycation Agent GLY-230 in Healthy Subjects
This study has been completed.
First Received: October 15, 2007   No Changes Posted
Sponsored by: Glycadia
Information provided by: Glycadia
ClinicalTrials.gov Identifier: NCT00544921
  Purpose

To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.


Condition Intervention Phase
Diabetes
Drug: GLY-230
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title: Phase 1 Study of Anti-Glycation Agent GLY-230

Further study details as provided by Glycadia:

Enrollment: 54
Study Start Date: October 2005
Study Completion Date: September 2006
  Eligibility

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

Inclusion Criteria:

  • Men age 18-55
  • Negative drug screen
  • Normal EKG, clinical chemistries, CBC, urinalysis, and
  • Give written informed consent

Exclusion Criteria:

  • Active concomitant serious medical or surgical disease,
  • Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544921

Locations
United States, Florida
Univ FL
Gainesville, Florida, United States
Sponsors and Collaborators
Glycadia
Investigators
Principal Investigator: Laurence Kennedy Univ. FLA Gainesville
  More Information

No publications provided

Study ID Numbers: GLY-001
Study First Received: October 15, 2007
Last Updated: October 15, 2007
ClinicalTrials.gov Identifier: NCT00544921     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Diabetes Mellitus
Healthy

ClinicalTrials.gov processed this record on May 06, 2009