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

NCT ID: NCT00544921

Last Updated: 2016-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-10-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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50 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

100 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

250 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

500 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

750 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

1000 mg

Group Type EXPERIMENTAL

GLY-230

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

No drug administered

Interventions

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GLY-230

Intervention Type DRUG

Placebo

No drug administered

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role collaborator

Glycadia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence Kennedy

Role: PRINCIPAL_INVESTIGATOR

Univ. FLA Gainesville

Locations

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Univ FL

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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GLY-001

Identifier Type: -

Identifier Source: org_study_id

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