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Completed

NCT Number: NCT00504439

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, NW10 7NS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-656933-AAA

Drug

The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally.

Other names: SB-656933

Matching Placebo

Drug

SB-656933-AAA matching placebo tablets will be administered orally.

simvastatin

Drug

Simvastatin will be provided as a 40 mg tablet.

Primary outcomes

  1. Assess safety of SB-656933 after repeat doses.

    Time frame: after repeat doses

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2007
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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