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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: SB-656933-AAA; Drug: Simvastatin; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504439

CR2100609

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

36 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Matching placebo

Drug: SB-656933-AAA

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Matching placebo

Drug: Simvastatin

Drug: SB-656933-AAA

Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Matching placebo

Drug: SB-656933-AAA