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

Study Overview
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Brief Summary
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To assess safety of SB-656933 following repeat dosing for 14 days.

Detailed Description
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: SB-656933-AAA
* Drug: Matching placebo
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days. | Drug: SB-656933-AAA<br>* 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.<br>* Other names: SB-656933;Drug: Matching placebo<br>* SB-656933-AAA matching placebo tablets will be administered orally.<br>|
| Experimental: Cohort 2<br>Subjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction. | Drug: SB-656933-AAA<br>* 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.<br>* Other names: SB-656933;Drug: Matching placebo<br>* SB-656933-AAA matching placebo tablets will be administered orally.<br>Drug: Simvastatin<br>* Simvastatin will be provided as a 40 mg tablet.<br>|
| Experimental: Cohort 3<br>Subjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing. | Drug: SB-656933-AAA<br>* 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.<br>* Other names: SB-656933;Drug: Matching placebo<br>* SB-656933-AAA matching placebo tablets will be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety of SB-656933 after repeat doses. |  | after repeat doses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD,, CD11b,, CXCR2,, safety,, repeat dose,, tolerability., SB-656933,