A Safety and PK Study of EC-18 in Healthy Subjects

Inclusion Criteria: * Females of childbearing potential must use an acceptable birth control method throughout the study and for 14 days after the dose of study drug. * Females of non-childbearing potential (defined as surgically sterilized \[tubal ligation/hysterectomy/bilateral salpingo-oophorectomy\] or postmenopausal for \>2 years) with a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit. * Males willing to practice contraception (condom + spermicide) during the study and for 14 days after completion of the study, or who have a female partner using barrier or oral contraception during that timeframe. * Body mass index (BMI) between 18 and 32 kg/m2, inclusive. * Ability to understand and give informed consent and provide authorization for use of protected health information (Health Insurance Portability and Accountability Act). * Willing and able to be confined to the research clinic as required by the protocol. Exclusion Criteria: * Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1. * Clinically significant laboratory findings at the Screening Visit defined as the following: * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin \>1.5 x upper limit of normal (ULN) * Blood urea nitrogen (BUN), creatinine \>1.25 x ULN * White blood cell (WBC) count \<0.9 x lower limit of normal (LLN) or \>1.1 x ULN * Hemoglobin or hematocrit \<0.9 x LLN or \>1.1 x ULN * Platelet count \<0.9 x LLN or \>1.1 x ULN * Glucose \<0.9 x LLN or \>1.25 x ULN * Thyroid-stimulating hormone (TSH) \<0.75 x LLN or \>1.25 x ULN or any other laboratory, ECG, vital sign, or physical abnormality that, in the investigator's opinion, unfavorably increases the risk of study participation. * Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity. * History of drug or alcohol abuse within the past 2 years. * Females who are pregnant or intend to get pregnant over the next month. * Positive urine pregnancy test at the Screening Visit or at admission to the research clinic on Day -1. * Positive urine drug or breath alcohol test at the Screening Visit or at admission to the research clinic on Day -1. Subjects should be instructed not to drink alcohol within 12 hours of the screening assessment. * Intake of alcohol within 72 hours prior to study drug administration or intake of grapefruit or Seville oranges within 7 days prior to the administration of study drug. * Strenuous physical exercise within 48 hours prior to study drug administration. * Administration of any over-the-counter medication, dietary supplements, or vitamins within 7 days prior to study drug administration. Excluded from this list is nondaily use of acetaminophen at doses of ≤2 grams over a 24-hour period. * Administration of prescription drugs or herbal supplements within 14 days prior to study drug administration. -.Exposure to any investigational agent within 30 days prior to the Screening Visit. * Any current medical illness, signs, or symptoms that, in the investigator's opinion, could adversely affect subject safety or study integrity.