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

Phase 2

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT00291902
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-15
• Study Start: 2006-03
• Status Verified: 2011-09
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)	28 days

Secondary Outcome Measures

Name	Time	Method
Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics	28 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇱 Poznan, Poland