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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504439

Enrollment

Registered

2007-07-20

Start date

2007-06-04

Completion date

2007-09-06

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD,, CD11b,, CXCR2,, safety,, repeat dose,, tolerability., SB-656933,

Brief summary

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

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.

Interventions

DRUGSB-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.

DRUGMatching placebo

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

DRUGSimvastatin

Simvastatin will be provided as a 40 mg tablet.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Assess safety of SB-656933 after repeat doses.	after repeat doses

Secondary

Measure	Time frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026