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

Coronary Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291902
• Other study ID #: PMK103351
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2006
• Last updated: May 31, 2012
• Start date: March 2006

Study information

• Verified date: September 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• SB-681323

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Esbjerg
Denmark	GSK Investigational Site	Haderslev
Denmark	GSK Investigational Site	Hellerup
Denmark	GSK Investigational Site	Herning
Denmark	GSK Investigational Site	Viborg
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)		28 days
Secondary	Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics		28 days