Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects

February 9, 2016 updated by: Glycadia

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

A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
No drug administered
Experimental: 250 mg
Drug: GLY-230
125, 250 0r 375 mg bid for 14 days
Experimental: 500 mg
Drug: GLY-230
125, 250 0r 375 mg bid for 14 days
Experimental: 750 mg
Drug: GLY-230
125, 250 0r 375 mg bid for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycated albumimin concentration
Time Frame: three weeks
three weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
urine albumin
Time Frame: three weeks
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glycadia

Investigators

  • Principal Investigator: Laurence Kennedy, M.D., University of Florida
  • Principal Investigator: Maria del Pilar Solano, M.D., University of Miami, Miami, Florida
  • Principal Investigator: Lis Cohen, D.O., Suncoast Clinical Research, New Port Richey, Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLY-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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