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

This study has been completed.

Sponsor:

Information provided by:

Glycadia

ClinicalTrials.gov Identifier:

NCT00544921

First received: October 15, 2007

Last updated: NA

Last verified: October 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 15, 2007

Last Updated Date

October 15, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 1 Study of Anti-Glycation Agent GLY-230

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Drug: GLY-230

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00544921

Other Study ID Numbers ^ICMJE

GLY-001

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Glycadia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Laurence Kennedy

Univ. FLA Gainesville

Information Provided By

Glycadia

Verification Date

October 2007

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

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