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AtherosclerosisPhase 1NCT01750827

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

A Phase 1 study testing SB659032 in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.

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 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Atherosclerosis
What is being tested?
SB659032
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Sep 2004to Nov 2004
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Single Dose Study to Assess the Effect of Non-Bioenhanced, Non-Enteric Coated, Freebase SB-659032 on Platelet Function in Healthy Adult Subjects

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

Conditions
Atherosclerosis
Being tested
SB659032
Keywords
platelet function, atherosclerosis,, SB-659032
Medical subject headings
Atherosclerosis

What participants receive

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

  • SB659032Drug

    single dose

Study groups in NCT01750827
Study groupRoleWhat they receive
SB-659032ExperimentalSingle dose open label
Receives: Drug: SB659032

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 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

    Measured: 24 hours

Secondary outcomes (3)

  1. PK of SB-659032 and SB-664601

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

    Measured: 24 hours

  2. Pharmacodynamics

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

    Measured: 24 hours

  3. Safety/tolerability

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

    Measured: 24 hours

Timeline

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

  1. First posted17 Dec 2012 (estimated)
  2. Study startSep 2004
  3. Primary completionNov 2004
  4. Study completionNov 2004

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01750827
Sponsor's protocol ID
102487
Status last verified
Dec 2012
First submitted
6 Dec 2012
Last updated
17 Dec 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB659032 in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.

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 2 inclusion and 15 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 17 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 United States. 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. 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: 24 hours). 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 NCT01750827.

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 17 Dec 2012.

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