Multiple Dose Trial of Anti-glycation Agent GLY-230 in He... | NCT00544934

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

NCT00544934

Sponsor

Glycadia

Status

Completed

Last Update Posted

Feb 10, 2016Estimated

Enrollment

42Actual

Phase

Phase 1Phase 2

Conditions

Diabetic Nephropathy

Interventions

GLY-230
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Oct 15, 2007

First Submission Date that Met QC Criteria

Oct 15, 2007

First Posted Date

Oct 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2016

Last Update Posted Date

Feb 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
250 mg	Experimental	Drug: GLY-230
500 mg	Experimental	Drug: GLY-230
750 mg	Experimental	Drug: GLY-230
Placebo	Placebo Comparator	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLY-230	Drug	125, 250 0r 375 mg bid for 14 days	250 mg 500 mg 750 mg

Measure	Description	Time Frame
glycated albumimin concentration		three weeks

Measure	Description	Time Frame
urine albumin		three weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C518289	2-(3-chlorophenylamino)phenylacetic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided