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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01750827
First received: December 6, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Drug: SB659032
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Platelet aggregation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • PK of SB-659032 and SB-664601 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cmax of SB-659032 and concentrations of SB-659032 at collection timepoints over

  • Pharmacodynamics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Plasma Lp-PLA2 activity, expressed in terms of percent inhibition

  • Safety/tolerability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Spontaneous AE reporting, 12-lead ECGs, vital signs, nursing/physician observation, and clinical laboratory tests


Enrollment: 14
Study Start Date: September 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB-659032
Single dose open label
Drug: SB659032
single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750827

Locations
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01750827     History of Changes
Other Study ID Numbers: 102487
Study First Received: December 6, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
platelet function
atherosclerosis,
SB-659032

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014