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

February 9, 2016 updated by: Glycadia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States
        • Univ FL

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:

  • 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

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
No drug administered
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
October, 2005 to October, 2006

Collaborators and Investigators

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

Sponsor

Glycadia

Collaborators

University of Florida

Investigators

  • Principal Investigator: Laurence Kennedy, Univ. FLA Gainesville

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

October 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

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

Other Study ID Numbers

  • GLY-001

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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