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

This study has been completed.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Glycadia
ClinicalTrials.gov Identifier:
NCT00544921
First received: October 15, 2007
Last updated: March 10, 2015
Last verified: March 2015
  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:

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 ] [ Designated as safety issue: No ]

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

  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
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 ClinicalTrials.gov identifier: NCT00544921

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

No publications provided

Responsible Party: Glycadia
ClinicalTrials.gov Identifier: NCT00544921     History of Changes
Other Study ID Numbers: GLY-001
Study First Received: October 15, 2007
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2015