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: February 9, 2016
Last verified: February 2016

October 15, 2007
February 9, 2016
October 2005
October 2006   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00544921 on ClinicalTrials.gov Archive Site
Not Provided
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Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects
Phase 1 Study of Anti-glycation Agent GLY-230
To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Diabetes
  • Drug: GLY-230
  • Other: Placebo
    No drug administered
  • Experimental: 50 mg
    Intervention: Drug: GLY-230
  • Experimental: 100 mg
    Intervention: Drug: GLY-230
  • Experimental: 250 mg
    Intervention: Drug: GLY-230
  • Experimental: 500 mg
    Intervention: Drug: GLY-230
  • Experimental: 750 mg
    Intervention: Drug: GLY-230
  • Experimental: 1000 mg
    Intervention: Drug: GLY-230
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00544921
GLY-001
No
Not Provided
Not Provided
Glycadia
Glycadia
University of Florida
Principal Investigator: Laurence Kennedy Univ. FLA Gainesville
Glycadia
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP