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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00291902
• Date of registration: 13/02/2006
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
• Scientific 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)
• Date of first enrolment: March 2006
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00291902
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Denmark, Italy, Luxembourg, Poland, Spain

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Heart Disease

Intervention(s)

Drug: SB-681323

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

PMK103351

Source(s) of Monetary Support

Please refer to primary and secondary sponsors