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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: placebo; Drug: GSK376501

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404963

DIX109177

Details and patient eligibility

About

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.

Full 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)

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind