Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Males and females who are 18 to 64 years of age inclusive, defined as young subjects in this study, are eligible for Cohorts 1-3 only
Males and females who are ≥65 years of age, defined as elderly subjects in this study, are eligible for Cohort 4 only
Healthy as determined by a responsible and experienced physician
A female subject is eligible to participate if she is of non-childbearing potential
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods
Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 19 and 32
Aspartate aminotransferase (AST), Alanine transaminase (ALT), alkaline phosphatase and bilirubin \<= 1.5xUpper Limit of Normal (ULN)
Average of triplicate QTcB values and average of triplicate QTcF values must both \< 450 msec
Capable of giving written informed consent
You may not be if
Subjects with Lp-PLA2 activity \<=20 nanomole/minute/milliliter (mL)(for subjects with 2 known birth parents of at least 50% Japanese, Chinese, or Korean ancestry)
History of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses
History of hypercoagulable state or history of thrombosis
History of biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology
Positive Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C at screening
History of regular use of tobacco or nicotine-containing products within 6 months of the study
Unable to abstain from alcohol or caffeine or xanthine-containing products for 24 h prior to the start of dosing
Unable to refrain from use of prescription or non-prescription drugs and vitamins within 7 days or 5 half-lives (whichever is longer) prior to administration of study
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening (Note: This applies to healthy young subjects screened for Cohorts 1-3 only. Healthy elderly subjects for cohort 4 who are social smokers must give up smoking for the period that they will be on the unit)
positive pre-study drug/alcohol screen
Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of study medication until the follow-up visit
Subjects who have taken statins, medicines that are contraindications of statins, know potent inhibitiors or inducers of CYP3A4 in the 4 weeks or 5 half-lives (whichever is longer) prior to screening and are not able to discontinue use throughout participation in the clinical trial
