Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects

Glycadia

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Other: Placebo; Drug: GLY-230

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00544921

GLY-001

Details and patient eligibility

About

To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men age 18-55
• Negative drug screen
• Normal EKG, clinical chemistries, CBC, urinalysis, and
• Give written informed consent

Exclusion criteria

• Active concomitant serious medical or surgical disease,
• Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days

Trial design

54 participants in 7 patient groups, including a placebo group

50 mg

Experimental group

Treatment:

Drug: GLY-230

100 mg

Experimental group

Treatment:

Drug: GLY-230

250 mg

Experimental group

Treatment:

Drug: GLY-230

500 mg

Experimental group

Treatment:

Drug: GLY-230

750 mg

Experimental group

Treatment:

Drug: GLY-230

1000 mg

Experimental group

Treatment:

Drug: GLY-230

Placebo

Placebo Comparator group

Treatment:

Other: Placebo