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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SB-656933-AAA
Matching placebo
Simvastatin
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD,, CD11b,, CXCR2,, safety,, repeat dose,, tolerability., SB-656933,

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Assess safety of SB-656933 after repeat doses.

Secondary Outcome Measures

Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.

Full Information

First Posted
July 18, 2007
Last Updated
August 2, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00504439
Brief Title
A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 4, 2007 (Actual)
Primary Completion Date
September 6, 2007 (Actual)
Study Completion Date
September 6, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD,, CD11b,, CXCR2,, safety,, repeat dose,, tolerability., SB-656933,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.
Arm Title
Cohort 2
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
SB-656933-AAA
Other Intervention Name(s)
SB-656933
Intervention Description
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
Intervention Name(s)
Matching placebo
Intervention Description
SB-656933-AAA matching placebo tablets will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Simvastatin will be provided as a 40 mg tablet.
Primary Outcome Measure Information:
Title
Assess safety of SB-656933 after repeat doses.
Time Frame
after repeat doses
Secondary Outcome Measure Information:
Title
Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.
Time Frame
14 days of repeat dosing.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
NW10 7NS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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