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

Phase 1

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: GLY-230; Other: Placebo

• Registration Number: NCT00544934
• Lead Sponsor: Glycadia

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 available

Study Timeline

• Study Start: 2007-02
• Study Completion: 2007-10
• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500 mg	GLY-230	-
750 mg	GLY-230	-
Placebo	Placebo	-
250 mg	GLY-230	-

Primary Outcome Measures

Name	Time	Method
glycated albumimin concentration	three weeks

Secondary Outcome Measures

Name	Time	Method
urine albumin	three weeks