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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-04

Study Completion Date

2007-09-06

Brief Summary

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

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Cohort 1

Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.

Group Type EXPERIMENTAL

SB-656933-AAA

Intervention Type 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.

Matching placebo

Intervention Type DRUG

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

Cohort 2

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.

Group Type EXPERIMENTAL

SB-656933-AAA

Intervention Type 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.

Matching placebo

Intervention Type DRUG

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

Simvastatin

Intervention Type DRUG

Simvastatin will be provided as a 40 mg tablet.

Cohort 3

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.

Group Type EXPERIMENTAL

SB-656933-AAA

Intervention Type 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.

Matching placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Matching placebo

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

Intervention Type DRUG

Simvastatin

Simvastatin will be provided as a 40 mg tablet.

Intervention Type DRUG

Other Intervention Names

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SB-656933

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes