Last updated: 07/13/2020 14:00:05
A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)
Timeframe: 28 days
Secondary outcomes:
Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics
Timeframe: 28 days
Interventions:
Drug: SB-681323
Enrollment:
80
Observational study model:
Not applicable
Primary completion date:
2007-03-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Coronary heart disease
Product
dilmapimod
Collaborators
Not applicable
Study date(s)
March 2006 to August 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- Females must be of non-child-bearing potential.
- Female subjects must have a negative pregnancy test.
- Women who are pregnant or breast feeding.
- Planned PCI with multi-vessel stenting.
Inclusion and 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-03-08
Actual study completion date
2007-03-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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