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

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: SB-656933-AAA; Drug: Matching placebo; Drug: Simvastatin

• Registration Number: NCT00504439
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2007-06-04
• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-20
• Primary Completion: 2007-09-06
• Study Completion: 2007-09-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	Matching placebo	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.
Cohort 1	SB-656933-AAA	Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.
Cohort 1	Matching placebo	Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.
Cohort 2	Matching placebo	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.
Cohort 2	SB-656933-AAA	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.
Cohort 3	SB-656933-AAA	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.
Cohort 2	Simvastatin	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.

Primary Outcome Measures

Name	Time	Method
Assess safety of SB-656933 after repeat doses.	after repeat doses

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom