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

Glycadia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Nephropathy

Treatments: Drug: GLY-230; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544934

GLY-002

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 4 patient groups, including a placebo group

250 mg

Experimental group

Treatment:

Drug: GLY-230

500 mg

Experimental group

Treatment:

Drug: GLY-230

750 mg

Experimental group

Treatment:

Drug: GLY-230

Placebo

Placebo Comparator group

Treatment:

Other: Placebo