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CompletedNCT01750827Updated Dec 17, 2012

A Study to Assess the Effect of SB 659032 on Platelet Function

A Phase 1 interventional study of SB659032 in Atherosclerosis, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This will be an open-label, single dose, single period study. Approximately 14 subjects will receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast. This study will evaluate whether SB-659032 has an effect on platelet function as determined by platelet aggregation tests using the agonists ADP and collagen. Blood samples for PK analysis and measurement of Lp-PLA2 activity will also be collected

02

Conditions studied

  • Atherosclerosis

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Keywords

  • platelet function
  • atherosclerosis,
  • SB-659032
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 14 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy males or females who are 18 to 55 years of age, inclusive.
  • Body weight greater than 50 kg (110 pounds) and body mass index (BMI) between 19 and 30 where: BMI = weight in kg (height in meters)2

Exclusion criteria

Exclusion Criteria:

  • Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG
  • History of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses
  • History of smoking within six months of the study and/or has a positive urine cotinine at screening
  • History of alcohol consumption exceeding, on average, 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the first dose of study medication
  • Positive urine drug or alcohol at screening
  • Use of aspirin, aspirin-containing products, non-steroidal anti-inflammatory agents or any antiplatelet medication within 14 days prior to the first dose of study medication (a list of these drugs will be reviewed with the subject at screening and provided to them to take home)
  • Use of prescription (including hormone replacement therapy) or non-prescription drugs and vitamins within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication. An exception is acetaminophen which is allowed at doses of less than and equal to 2g/day for up to 48 hours prior to dosing
  • Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng and red yeast rice within 14 days prior to treatment with study medication
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing
  • Consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication
  • A history of biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology
  • Pregnant or nursing female subjects. For female subjects, a positive serum β-hCG at screening or Day -1; or for female subjects of childbearing potential an unwillingness to agree to one of the methods of contraception listed in the protocol from screening until the completion of follow-up procedures. Hormonal contraceptive methods (e.g. oral contraceptive pill, implant) for female subjects are not permitted. At least a one week interval between screening and first study drug administration will be observed for the pregnancy tests.
  • For male subjects, an unwillingness to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study Donation of blood in excess of 500 mL within 56 days prior to dosing
  • Full ADP- and/or collagen-induced aggregation (greater than and equal to 40%) at all three concentrations of one or both agonists, as assessed on Day -1
  • No ADP- or collagen-induced aggregation (\<40%) at the highest concentration of either agonist, as assessed on Day -1
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    SB-659032

    Single dose open label

    Drug: SB659032

Interventions

  • DrugSB659032

    single dose

06

What researchers measure

Primary outcomes

  1. Platelet aggregation

    Percent maximum platelet aggregation following ADP- and collagen-induced aggregation a 24-hour post-dose period. Other pharmacokinetic endpoints of interest are Tmax of SB-659032 and its pharmacologically active metabolite, SB-664601, as well as Cmax of SB-664601 and concentrations of SB-664601 over a 24-hour post-dose

    Time frame: 24 hours

Secondary outcomes

  1. PK of SB-659032 and SB-664601

    Cmax of SB-659032 and concentrations of SB-659032 at collection timepoints over

    Time frame: 24 hours

  2. Pharmacodynamics

    Plasma Lp-PLA2 activity, expressed in terms of percent inhibition

    Time frame: 24 hours

  3. Safety/tolerability

    Spontaneous AE reporting, 12-lead ECGs, vital signs, nursing/physician observation, and clinical laboratory tests

    Time frame: 24 hours

07

Study locations

1 site
  • GSK Investigational Site
    Lenexa, Kansas 66219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01750827
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 17, 2012
Start date
Sep 2004
Primary completion
Nov 2004
Completion
Nov 2004
Last update
Dec 17, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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