Phase 1 Study of Anti-Glycation Agent GLY-230 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Glycadia
ClinicalTrials.gov Identifier:
NCT00544921
First received: October 15, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

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

ClinicalTrials.gov processed this record on April 17, 2014