A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00404963

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: placebo Drug: GSK376501	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind, Parallel Assignment, Safety Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers [ Time Frame: throughout the study ]

Enrollment:	72
Study Start Date:	October 2006

Detailed Description:

A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study with Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion:

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

Exclusion:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404963

Locations

United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, MPH

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	DIX109177
Study First Received:	November 27, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00404963 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

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

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Overweight
Endocrinopathy
Healthy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 03, 2009