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

Glycadia42 enrolled

Overview

A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Nephropathy

Interventions

GLY-230DRUG

125, 250 0r 375 mg bid for 14 days

PlaceboOTHER

No drug administered

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

glycated albumimin concentration

Time frame: three weeks

Secondary Outcomes

urine albumin

Time frame: three weeks

Data from ClinicalTrials.gov

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