A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects

GlaxoSmithKline72 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

placeboDRUG

GSK376501DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: throughout the study

Data from ClinicalTrials.gov

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