NCT00544921

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Oct 2005

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

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

October 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 year 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

Enrollment Period

1 year

First QC Date

October 15, 2007

Last Update Submit

February 9, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (7)

50 mg

EXPERIMENTAL
Drug: GLY-230

100 mg

EXPERIMENTAL
Drug: GLY-230

250 mg

EXPERIMENTAL
Drug: GLY-230

500 mg

EXPERIMENTAL
Drug: GLY-230

750 mg

EXPERIMENTAL
Drug: GLY-230

1000 mg

EXPERIMENTAL
Drug: GLY-230

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

GLY-230DRUG
100 mg1000 mg250 mg50 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:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ FL

Gainesville, Florida, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

2-(3-chlorophenylamino)phenylacetic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Laurence Kennedy

    Univ. FLA Gainesville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

October 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

US(1)