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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00504439
First Posted: July 20, 2007
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
To assess safety of SB-656933 following repeat dosing for 14 days.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: SB-656933-AAA Drug: Matching placebo Drug: Simvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Assess safety of SB-656933 after repeat doses. [ Time Frame: 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. [ Time Frame: 14 days of repeat dosing. ]

Enrollment: 36
Actual Study Start Date: June 4, 2007
Study Completion Date: September 6, 2007
Primary Completion Date: September 6, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: SB-656933
Drug: Matching placebo
SB-656933-AAA matching placebo tablets will be administered orally.
Experimental: 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.
Drug: 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.
Other Name: SB-656933
Drug: Matching placebo
SB-656933-AAA matching placebo tablets will be administered orally.
Drug: Simvastatin
Simvastatin will be provided as a 40 mg tablet.
Experimental: 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.
Drug: 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.
Other Name: SB-656933
Drug: Matching placebo
SB-656933-AAA matching placebo tablets will be administered orally.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504439


Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00504439     History of Changes
Other Study ID Numbers: CR2100609
First Submitted: July 18, 2007
First Posted: July 20, 2007
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
COPD,
CD11b,
CXCR2,
safety,
repeat dose,
tolerability.
SB-656933,

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors