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

This study has been completed.
University of Florida
Information provided by (Responsible Party):
Glycadia Identifier:
First received: October 15, 2007
Last updated: February 9, 2016
Last verified: February 2016
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 Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Phase 1 Study of Anti-glycation Agent GLY-230

Further study details as provided by Glycadia:

Primary Outcome Measures:
  • A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects [ Time Frame: October, 2005 to October, 2006 ]

Enrollment: 54
Study Start Date: October 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg Drug: GLY-230
Experimental: 100 mg Drug: GLY-230
Experimental: 250 mg Drug: GLY-230
Experimental: 500 mg Drug: GLY-230
Experimental: 750 mg Drug: GLY-230
Experimental: 1000 mg Drug: GLY-230
Placebo Comparator: Placebo Other: Placebo
No drug administered


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
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Please refer to this study by its identifier: NCT00544921

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

Responsible Party: Glycadia Identifier: NCT00544921     History of Changes
Other Study ID Numbers: GLY-001
Study First Received: October 15, 2007
Last Updated: February 9, 2016 processed this record on August 18, 2017