SB-659032 Platelet Aggregation Study

NCT01745458 | Completed Phase 1

• 1 other identifier: 104623
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• Platelet aggregation

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

  14 days

• Biomarkers of platelet aggregation

  Urinary 11-dehydrothromboxane B2 and blood CD62 concentrations

  14 days

Secondary Outcomes (4)

• Lp-PLA2 inhibition

  14 days

• Clinical safety data

  14 days

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

  14 days

• Frequency and intensity of odor-related adverse events

  14 days

Study Arms (2)

SB-659032

EXPERIMENTAL

250 mg non-enteric coated SB-659032

Drug: Placebo

Placebo

PLACEBO COMPARATOR

matched placebo QD for 14 days

Drug: SB-659032

Interventions

SB-659032 DRUG

Placebo

Placebo DRUG

Matched placebo

SB-659032

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

• 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.

  PMID: 24475026 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

rilapladib

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: July 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

AU (1)