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

NCT ID: NCT00544934

Last Updated: 2016-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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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

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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250 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

125, 250 0r 375 mg bid for 14 days

500 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

125, 250 0r 375 mg bid for 14 days

750 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

125, 250 0r 375 mg bid for 14 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

No drug administered

Interventions

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GLY-230

125, 250 0r 375 mg bid for 14 days

Intervention Type DRUG

Placebo

No drug administered

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Glycadia

INDUSTRY

Sponsor Role lead

Principal Investigators

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Laurence Kennedy, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Maria del Pilar Solano, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami, Miami, Florida

Lis Cohen, D.O.

Role: PRINCIPAL_INVESTIGATOR

Suncoast Clinical Research, New Port Richey, Florida

Other Identifiers

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GLY-002

Identifier Type: -

Identifier Source: org_study_id

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