Dyslipidemia Self-Scheduler

Basic Criteria 

• Age: 18-65 years old 
• Gender: Men and women (women must be postmenopausal or surgically sterilized) 
• BMI: Between 18-35 
• Availability: Must stay at research facility for 22 days and attend 1 follow-up visit  

Exclusion Questions – Answers Must Be NO 

1. Do you have any ongoing health conditions or take any medications regularly? 

1. Do you regularly take any prescription medications, over-the-counter medications, vitamins, or herbal supplements? (Acetaminophen/Tylenol and hormone replacement therapy are allowed) 

1. For men: Are you unwilling or unable to use appropriate contraception and avoid fathering a child for 3 months after the study? 

1. For women: are you of childbearing potential, currently pregnant, nursing or breastfeeding? 

1. Do you drink more than 5 cups of coffee per day or consume excessive amounts of caffeine? 

1. Do you have a history of drug or alcohol abuse, or do you drink alcohol heavily?  

1. Do you have high or low blood pressure that requires medication (≥140/90)? 

1. Do you currently smoke or use any cigarettes, use e-cigarettes, vape, or use any nicotine products in the last 3months?  

1. Do you regularly take any prescription medications, over-the-counter medications, vitamins, or herbal supplements? (Acetaminophen/Tylenol and hormone replacement therapy are allow 

1. Have you used any medications that affect the liver in the past 3 weeks? (Such as St. John’s Wort) 

1. Do you have any known bleeding disorders, blood clotting problems, or take blood thinners? (This includes conditions like hemophilia, frequent nosebleeds, easy bruising, or medications like warfarin, Coumadin, or daily aspirin) 

1. Have you been diagnosed with any heart, liver, kidney, stomach, or intestinal diseases? (This includes hepatitis, kidney stones, heart disease, chronic stomach problems, etc.) 

1. Have you been hospitalized, had surgery, or been seriously ill within the past month? 

1. Do you have a personal or family history of heart rhythm problems, including long QT syndrome? 

1. Do you currently have HIV, hepatitis B, or hepatitis C? 

1. Have you donated plasma within the past month? 

1. Have you donated or lost more than 500 mL (one pint) of blood within the past 3 months? 

1. Do you have any medical dietary restrictions or unable to comply with meals provided at the clinic? 

1. Are you in detention, a protected adult under guardianship, trusteeship, or committed to an institution by governmental or juridical order? 

1. Do you have kidney problems, or have you been told your kidney function is reduced? 

1. Have you participated in any other research studies in the past month? 

1. Are you allergic to any medications or have you had severe allergic reactions? 

Answers Must Be YES 

1. Are you generally in good health? 

1. Are you able to stay at the research facility for 22 days during the residential portion? 

1. Are you willing to avoid alcohol, smoking, and follow dietary restrictions during the study? 

1. Are you able to fast overnight before taking the study medication when required? 

1. If female of non-childbearing potential, do you meet one of the following requirements? 

• • Postmenopausal defined as no cycle for 12 months without an alternative medical cause 

• • Documented: hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks prior to first visit. 

1. Are you willing to refrain from consuming poppy seeds, red wine, Seville oranges, grapefruit, or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, citrus fruit juices, liquorice, or quinine at certain times during the study? 

1. If male, are you willing to refrain from sperm donation throughout the study? 

Additional Criteria May Apply