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Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Atherosclerosis

Treatments

Drug: SB-480848 80 mg
Drug: SB-480848 40 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01916720
480848/010

Details and patient eligibility

About

The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and plaque, specified biomarkers in blood and plaque and their respective correlation's with Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of SB-480848, and safety and tolerability in this population.

Enrollment

103 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female, >35 years of age
  • Females of childbearing potential must be using approved contraceptive measures
  • Male patients must be willing to abstain from sexual intercourse or use a form of contraception if engaging in sexual intercourse with a woman who could become pregnant
  • Planned carotid endarterectomy within a timeframe compatible with recruitment for the study and able to comply with the requirements of the study, as deemed by the investigator
  • Written, informed consent to participate

Exclusion criteria

  • Recent myocardial infarction (within the previous 4 weeks)
  • Currently taking corticosteroids, warfarin, digoxin or a potent CYP3A4 inhibitor
  • Recent (<3 months) or ongoing acute infection or significant trauma associated with bruising and/or taking antibiotics. Prophylactic antibiotics for surgery are allowed
  • Change in dose of lipid-lowering therapy during the previous 4 weeks from randomisation
  • History of chronic liver disease (e.g. cirrhosis, hepatitis) OR ALT OR AST ≥1.5 times the upper limit of normal (ULN) at screening
  • Diagnosis of systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA)
  • Clinically significant anaemia
  • History of severe renal impairment (serum creatinine >1.8mg/dL)
  • Unstable angina
  • History of asthma , anaphylaxis or anaphylactoid reactions, severe allergic responses
  • Abuse of alcohol or drugs within the last 6 months
  • Any factor or clinical disease state that, in the investigator's opinion, would preclude completion of a safe surgical procedure and/or completion of the study
  • Use of an investigational drugs within 30 days or 5 half-lives of their last dose prior to starting the study, whichever is the longest

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

103 participants in 3 patient groups, including a placebo group

SB-480848 40 mg
Experimental group
Description:
SB-480848 40 milligrams (mg) once a day (od) for 14 +/- 4 days followed by carotid endarterectomy. SB-480848 40 mg was administered as 2 SB-480848 20 mg tablets plus 2 placebo tablets.
Treatment:
Drug: Placebo
Drug: SB-480848 40 mg
SB-480848 80 mg
Experimental group
Description:
SB-480848 80 mg od for 14 +/- 4 days followed by carotid endarterectomy.SB-480848 80 mg was administered as 4 20 mg SB-480848 tablets.
Treatment:
Drug: SB-480848 80 mg
Matching Placebo
Placebo Comparator group
Description:
Placebo for 14 +/- 4 days followed by carotid endarterectomy. Placebo was administered as 4 placebo tablets. Placebo tablets were identical in appearance to the SB-480848 20 mg tablets.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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