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NCT00504439 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00504439
Other study ID # CR2100609
Secondary ID
Status Completed
Phase Phase 1
First received July 18, 2007
Last updated August 2, 2017
Start date June 4, 2007
Est. completion date September 6, 2007

Study information
Verified date August 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date September 6, 2007
Est. primary completion date September 6, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SB-656933-AAA
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.
• Matching placebo
SB-656933-AAA matching placebo tablets will be administered orally.
• Simvastatin
Simvastatin will be provided as a 40 mg tablet.

Locations
Country Name City State
United Kingdom GSK Investigational Site London

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess safety of SB-656933 after repeat doses. after repeat doses
Secondary Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing. 14 days of repeat dosing.
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