Back to resultsMultiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
Primary Purpose
Diabetic Nephropathy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
GLY-230
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent
Exclusion Criteria:
- Sctive concomitant serious medical or surgical disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
250 mg
500 mg
750 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
glycated albumimin concentration
Secondary Outcome Measures
urine albumin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544934
Brief Title
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
Official Title
A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Glycadia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
250 mg
Arm Type
Experimental
Arm Title
500 mg
Arm Type
Experimental
Arm Title
750 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GLY-230
Intervention Description
125, 250 0r 375 mg bid for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
No drug administered
Primary Outcome Measure Information:
Title
glycated albumimin concentration
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
urine albumin
Time Frame
three weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent
Exclusion Criteria:
Sctive concomitant serious medical or surgical disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Kennedy, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria del Pilar Solano, M.D.
Organizational Affiliation
University of Miami, Miami, Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lis Cohen, D.O.
Organizational Affiliation
Suncoast Clinical Research, New Port Richey, Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
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