A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.

May 31, 2012 updated by: GlaxoSmithKline

A Single Dose, Randomized, 5-Period, Balanced, Crossover Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK364735 and Pharmacokinetics Following a Double Blind, Placebo Controlled, Repeat Dose Administration to Healthy Subjects.

This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

56

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

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47714
        • 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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • The subject is healthy with no clinically significant problems identified by the physician.
  • Females of non-childbearing potential and males surgically sterile or agrees to birth control.
  • Body mass Index (BMI) of 19-29.9 (kg/m2).

Exclusion criteria:

  • As a result of the physical examination, lab results the Investigator considers the subject unfit for the study.
  • Blood pressure and electrocardiogram is not normal
  • A history of alcohol or illicit drug abuse.
  • Tobacco use within 3 months.
  • Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody.
  • Current use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
  • Has participated in a clinical trial within 30 days prior to the first dose of study medication.
  • Donated a pint of blood within a 56 day period.
  • History of allergy to study drug.

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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax

Secondary Outcome Measures

Outcome Measure
Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.

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

October 1, 2006

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 6, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRZ108532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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