Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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

Condition Intervention Phase
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00544921

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

No publications provided 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 processed this record on February 27, 2015