NCT00404963

Brief Summary

This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability. The way the human body processes GSK376501 will also be determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2006

Typical duration for phase_1 type-2-diabetes-mellitus

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, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

November 27, 2006

Last Update Submit

January 18, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

GSK376501,First Time in Human,Single Dose,Dose Escalation,Healthy Overweight/Obese Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety will be monitored by assessing adverse reactions,changes in laboratory values (hematology, clinical chemistry, urinalysis),changes in vital signs (oral body temperature,60 second respiratory rate, blood pressure and heart rate), and ECG changes.

    throughout the study

Secondary Outcomes (1)

  • Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers

    throughout the study

Interventions

placeboDRUG
GSK376501DRUG
Also known as: placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Non-smoking
  • Overweight or obese subjects with a BMI between 27 and 35.

You may not qualify if:

  • Women who are pregnant, lactating, or are of child-bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • GSK Clinical Trials, MD, MPH

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 29, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

US(1)