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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: July 18, 2007
Last updated: January 18, 2017
Last verified: January 2017
To assess safety of SB-656933 following repeat dosing for 14 days.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: SB-656933 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00504439

United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00504439     History of Changes
Other Study ID Numbers: CR2100609
Study First Received: July 18, 2007
Last Updated: January 18, 2017

Keywords provided by GlaxoSmithKline:
repeat dose,

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on June 27, 2017