GSK372475 Bioequivalence Study

May 31, 2012 updated by: GlaxoSmithKline

An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.

The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: GSK372475

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M1L 4S4
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy Males/Females aged 18-45 years
Non-smokers
BMI 19-30 kg.m2
QTc<450msec

Exclusion Criteria:

Use of oral contraception
Positive breath alcohol and drug screen
Regular alcohol consumption
Current psychiatric illness or within 1 year.
History of GI, hepatic or renal disease
Uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax Time Frame: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.	at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events Time Frame: all visits	all visits
vitals (all visits) + ECG Time Frame: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.	at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
labs Time Frame: at screening and 2 weeks post dose	at screening and 2 weeks post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria