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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544921
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : February 10, 2016
University of Florida
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Drug: GLY-230 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Phase 1 Study of Anti-glycation Agent GLY-230
Study Start Date : October 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544921

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

Responsible Party: Glycadia Identifier: NCT00544921     History of Changes
Other Study ID Numbers: GLY-001
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016