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

May 31, 2012 updated by: GlaxoSmithKline

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • GSK Investigational Site
      • Haderslev, Denmark, 6100
        • GSK Investigational Site
      • Hellerup, Denmark, 2900
        • GSK Investigational Site
      • Herning, Denmark, 7400
        • GSK Investigational Site
      • Viborg, Denmark, 8800
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-276
        • GSK Investigational Site
      • Poznan, Poland, 60-355
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMK103351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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