A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects.

This study has been completed.

First Received: July 18, 2007 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00504439

Purpose

To assess safety of SB-656933 following repeat dosing for 14 days.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: SB-656933	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: SB 656933

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Assess safety of SB-656933 after repeat doses. [ Time Frame: after repeat doses ]

Secondary Outcome Measures:

Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing. [ Time Frame: 14 days of repeat dosing. ]

Enrollment:	36
Study Start Date:	June 2007
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

A randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also be assessed.

Eligibility

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

Criteria

Inclusion Criteria:

Healthy adult female, aged 18-65 years.
Female must not be able to have children.
Non-smoking for the last 6 months.

Exclusion Criteria:

Any serious medical condition.
Hepatitis B or C and/or HIV positive.
Currently on HRT, or other medication except paracetamol.
Body Mass Index >30.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504439

Locations

United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CR2100609
Study First Received:	July 18, 2007
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00504439 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

SB-656933,
COPD,
CXCR2,
CD11b,

repeat dose,
safety,
tolerability.

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Healthy
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 11, 2009