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

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: GLY-230; Other: Placebo

• Registration Number: NCT00544921
• Lead Sponsor: Glycadia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• 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: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg	GLY-230	-
100 mg	GLY-230	-
Placebo	Placebo	-
750 mg	GLY-230	-
250 mg	GLY-230	-
500 mg	GLY-230	-
1000 mg	GLY-230	-

Primary Outcome Measures

Name	Time	Method
A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects	October, 2005 to October, 2006

Trial Locations

Locations (1)

Univ FL; 🇺🇸 Gainesville, Florida, United States