Expired Study
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Raleigh, North Carolina 27612


Purpose:

The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.


Study summary:

This will be a randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort of subjects will not occur until a review of the safety and tolerability data from the previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor together confirm the safety and tolerability of EC-18 given at that dose level.


Criteria:

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.


NCT ID:

NCT02496143


Primary Contact:

Principal Investigator
Treva W Tyson, MD
Wake Research Associates


Backup Contact:

N/A


Location Contact:

Raleigh, North Carolina 27612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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