Expired Study
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Gainesville, Florida


Purpose:

To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.


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


Study is Available At:


Original ID:

GLY-001


NCT ID:

NCT00544921


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Phase 1 Study of Anti-glycation Agent GLY-230


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Glycadia


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: P


Number of Arms:

7


Number of Groups:

0


Total Enrollment:

54


Enrollment Type:

Actual


Overall Contact Information

Official Name:Laurence Kennedy
Principal Investigator
Univ. FLA Gainesville

Study Dates

Start Date:October 2005
Completion Date:October 2006
Completion Type:Actual
Primary Completion Date:October 2006
Primary Completion Type:Actual
Verification Date:February 2016
Last Changed Date:February 9, 2016
First Received Date:October 15, 2007

Study Outcomes

Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:GLY-230
Arm Name:50 mg
Intervention Type:Other
Name:Placebo
Description:No drug administered
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:50 mg
Study Arm Type:Experimental
Arm Name:100 mg
Study Arm Type:Experimental
Arm Name:250 mg
Study Arm Type:Experimental
Arm Name:500 mg
Study Arm Type:Experimental
Arm Name:750 mg
Study Arm Type:Experimental
Arm Name:1000 mg
Study Arm Type:Placebo Comparator
Arm Name:Placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glycadia
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Florida

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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