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A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB-681323
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring CHD, coronary heart disease, atherosclerosis, inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Females must be of non-child-bearing potential. Female subjects must have a negative pregnancy test. Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography. Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL <130 mg/dL (3.4 mmol/L) at Screening visit. Must be capable of providing informed consent. Have an hsCRP concentration of >2 mg/L, but < 10 mg/L at screening. Exclusion Criteria: Women who are pregnant or breast feeding. Planned PCI with multi-vessel stenting. Planned PCI with additional revascularization procedures staged at different days during the study period. Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc). Planned PCI of any bypass graft. History of CABG surgery. Planned cardiac or major non-cardiac surgery within the study period. Disabling stroke in the past 6 months. History of chronic viral hepatitis or other chronic hepatic disorders. History of Gilbert's syndrome or elevated bilirubin concentrations at screening. History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months. Renal impairment with serum creatinine >2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy. Current inadequately controlled hypertension (blood pressure >160 mmHg systolic and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication. Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screening. History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF<30%) regardless of symptomatic status. History of malignancy within the past 5 years, other than non-melanoma skin cancer. Current life-threatening condition other than vascular disease that may prevent a subject from completing the study. Alcohol or drug abuse within the past 6 months.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)

Secondary Outcome Measures

Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics

Full Information

First Posted
February 13, 2006
Last Updated
May 31, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00291902
Brief Title
A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
Official Title
A 28-day, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 (7.5 mg) in Subjects With Coronary Heart Disease (CHD) Undergoing Elective Percutaneous Coronary Interventions (PCI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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
Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
CHD, coronary heart disease, atherosclerosis, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB-681323
Primary Outcome Measure Information:
Title
Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females must be of non-child-bearing potential. Female subjects must have a negative pregnancy test. Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography. Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL <130 mg/dL (3.4 mmol/L) at Screening visit. Must be capable of providing informed consent. Have an hsCRP concentration of >2 mg/L, but < 10 mg/L at screening. Exclusion Criteria: Women who are pregnant or breast feeding. Planned PCI with multi-vessel stenting. Planned PCI with additional revascularization procedures staged at different days during the study period. Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc). Planned PCI of any bypass graft. History of CABG surgery. Planned cardiac or major non-cardiac surgery within the study period. Disabling stroke in the past 6 months. History of chronic viral hepatitis or other chronic hepatic disorders. History of Gilbert's syndrome or elevated bilirubin concentrations at screening. History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months. Renal impairment with serum creatinine >2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy. Current inadequately controlled hypertension (blood pressure >160 mmHg systolic and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication. Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screening. History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF<30%) regardless of symptomatic status. History of malignancy within the past 5 years, other than non-melanoma skin cancer. Current life-threatening condition other than vascular disease that may prevent a subject from completing the study. Alcohol or drug abuse within the past 6 months.
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
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
GSK Investigational Site
City
Haderslev
ZIP/Postal Code
6100
Country
Denmark
Facility Name
GSK Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
GSK Investigational Site
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
GSK Investigational Site
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20689074
Citation
Sarov-Blat L, Morgan JM, Fernandez P, James R, Fang Z, Hurle MR, Baidoo C, Willette RN, Lepore JJ, Jensen SE, Sprecher DL. Inhibition of p38 mitogen-activated protein kinase reduces inflammation after coronary vascular injury in humans. Arterioscler Thromb Vasc Biol. 2010 Nov;30(11):2256-63. doi: 10.1161/ATVBAHA.110.209205. Epub 2010 Aug 5.
Results Reference
derived

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A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention

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