NCT00544934

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

First QC Date

October 15, 2007

Last Update Submit

February 9, 2016

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • glycated albumimin concentration

    three weeks

Secondary Outcomes (1)

  • urine albumin

    three weeks

Study Arms (4)

250 mg

EXPERIMENTAL
Drug: GLY-230

500 mg

EXPERIMENTAL
Drug: GLY-230

750 mg

EXPERIMENTAL
Drug: GLY-230

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

GLY-230DRUG

125, 250 0r 375 mg bid for 14 days

250 mg500 mg750 mg
PlaceboOTHER

No drug administered

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Sctive concomitant serious medical or surgical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

2-(3-chlorophenylamino)phenylacetic acid

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Laurence Kennedy, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Maria del Pilar Solano, M.D.

    University of Miami, Miami, Florida

    PRINCIPAL INVESTIGATOR

  • Lis Cohen, D.O.

    Suncoast Clinical Research, New Port Richey, Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

February 1, 2007

Study Completion

October 1, 2007

Last Updated

February 10, 2016

Record last verified: 2016-02