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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01745458




Registration number
NCT01745458
Ethics application status
Date submitted
6/12/2012
Date registered
10/12/2012
Date last updated
10/12/2012

Titles & IDs
Public title
SB-659032 Platelet Aggregation Study
Scientific title
A Double Blind Study to Evaluate Effects of Repeat Doses of SB-659032 on Platelet Aggregation in Healthy Volunteers
Secondary ID [1] 0 0
104623
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB-659032
Treatment: Drugs - Placebo

Experimental: SB-659032 - 250 mg non-enteric coated SB-659032

Placebo Comparator: Placebo - matched placebo QD for 14 days


Treatment: Drugs: SB-659032


Treatment: Drugs: Placebo
Matched placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Platelet aggregation
Timepoint [1] 0 0
14 days
Primary outcome [2] 0 0
Biomarkers of platelet aggregation
Timepoint [2] 0 0
14 days
Secondary outcome [1] 0 0
Lp-PLA2 inhibition
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Clinical safety data
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Mean concentrations of SB-659032 and its major metabolite, SB-664601
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
Frequency and intensity of odor-related adverse events
Timepoint [4] 0 0
14 days

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01745458
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01745458