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AtherosclerosisPhase 1NCT01745458

SB-659032 Platelet Aggregation Study

A Phase 1 study testing SB-659032 in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma biomarkers. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Atherosclerosis
What is being tested?
SB-659032
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteAustralia
Study dates
Jul 2005to Dec 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult males between 18 and 55 years of age, inclusive
  • Body weight greater than 50 kg (110 pounds) and body mass index (BMI) between 19 and 32 where: BMI = weight in kg/(height in meters)2
  • A signed and dated written informed consent prior to admission to the study
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Who cannot join

  • Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG
  • Platelet count below or above the reference range
  • History of hypercoagulable state or history of thrombosis
  • History of platelet dysfunction
  • A known history of Gilbert's Syndrome
  • History of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses
Show all 20Show fewer
  • A history of alcohol, substance or drug abuse within the last year or a positive alcohol breath test at screening or predose in each period. Abuse of alcohol is defined as an average weekly intake of greater than or equal to 21 units (male) or an average daily intake of greater than or equal to 3 units (male). 1 unit is equivalent to a 285mL glass of full strength beer or 425 mL schooner of light beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine
  • Positive urine drug screen at screening or predose in each period
  • History of use of tobacco or nicotine containing products within 6 months of screening or a positive urine cotinine at screening or exhaled carbon monoxide test at predose in each period
  • Positive HIV, Hepatitis B or Hepatitis C at screening
  • Use of aspirin, aspirin-containing products, non-steroidal anti-inflammatory agents or any antiplatelet medication within 14 days prior to Day -1 of the study (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 Day -1 of the study. An exception is acetaminophen which is allowed at doses of ≤ 2g/day
  • 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 Day -1 of the study
  • 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 Day -1 of the study
  • A history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology
  • 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 or donation of blood in excess of 250 mL within 7 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 within 6 months prior to first dose and at Day -1 of each period
  • No ADP- or collagen-induced aggregation (less than 40%) at the highest concentration of either agonist, as assessed within 6 months prior to first dose and at Day -1 of each period

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • GSK Investigational Site

    Randwick, Sydney, New South Wales, 2031

Other trials in Australia

About this study

Official title: A Double Blind Study to Evaluate Effects of Repeat Doses of SB-659032 on Platelet Aggregation in Healthy Volunteers

This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma biomarkers.

Read the detailed description

SB-659032 is a selective and orally active inhibitor of lipoprotein-associated phospholipase A2 (Lp-PLA2) that is being developed for the treatment of atherosclerosis. This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma biomarkers. Blood samples for PK analysis and measurement of Lp-PLA2 activity will also be collected. Questionnaires will be completed to evaluate the frequency of odorrelated AEs with non-enteric coated formulation of SB-659032 relative to placebo. This will be a double blind, repeat dose, randomized, placebo-controlled, two period, period balanced, crossover study. There will be a minimum of a 21 day washout period between dosing in each period.

Conditions
Atherosclerosis
Being tested
SB-659032, Placebo
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB-659032Drug

  • PlaceboDrug

    Matched placebo

Study groups in NCT01745458
Study groupRoleWhat they receive
SB-659032Experimental250 mg non-enteric coated SB-659032
Receives: Drug: Placebo
PlaceboPlacebo comparatormatched placebo QD for 14 days
Receives: Drug: SB-659032

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet aggregation

    Percent maximum platelet aggregation following ADP- and collagen-induced aggregation

    Measured: 14 days

  2. Biomarkers of platelet aggregation

    Urinary 11-dehydrothromboxane B2 and blood CD62 concentrations

    Measured: 14 days

Secondary outcomes (4)

  1. Lp-PLA2 inhibition

    Lp-PLA2 activity, expressed in terms of percent inhibition relative to baseline

    Measured: 14 days

  2. Clinical safety data

    spontaneous adverse event reporting, 12-Lead ECG, vital signs, nursing/physician observation and safety and laboratory tests

    Measured: 14 days

  3. Mean concentrations of SB-659032 and its major metabolite, SB-664601

    SB-659032 and SB-664601 concentrations

    Measured: 14 days

  4. Frequency and intensity of odor-related adverse events

    The frequency and intensity of odor-related adverse events as reported by subjects will be summarized

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2012 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01745458
Sponsor's protocol ID
104623
Status last verified
Dec 2012
First submitted
6 Dec 2012
Last updated
10 Dec 2012
Results posted
No

Publications

  • Shaddinger BC, Xu Y, Roger JH, Macphee CH, Handel M, Baidoo CA, Magee M, Lepore JJ, Sprecher DL. Platelet aggregation unchanged by lipoprotein-associated phospholipase A(2) inhibition: results from an in vitro study and two randomized phase I trials. PLoS One. 2014 Jan 27;9(1):e83094. doi: 10.1371/journal.pone.0083094. eCollection 2014.

    PubMed 24475026

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB-659032 in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet aggregation (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01745458, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.

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SB-659032 Platelet Aggregation Study (NCT01745458) | AzTrials