A Safety and PK Study of EC-18 in Healthy Subjects
- Registration Number
- NCT02496143
- Lead Sponsor
- Enzychem Lifesciences Corporation
- Brief Summary
The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
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Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1.
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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.
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Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.
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History of drug or alcohol abuse within the past 2 years.
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Females who are pregnant or intend to get pregnant over the next month.
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Positive urine pregnancy test at the Screening Visit or at admission to the research clinic on Day -1.
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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.
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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.
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Strenuous physical exercise within 48 hours prior to study drug administration.
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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.
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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.
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Any current medical illness, signs, or symptoms that, in the investigator's opinion, could adversely affect subject safety or study integrity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 2 EC-18 1000 mg EC-18 dose orplacebo Cohort 3 EC-18 2000 mg EC-18 dose or placebo Cohort 1 EC-18 500 mg EC-18 dose or placebo Cohort 3 Placebo 2000 mg EC-18 dose or placebo Cohort 1 Placebo 500 mg EC-18 dose or placebo Cohort 2 Placebo 1000 mg EC-18 dose orplacebo Cohort 4 EC-18 4000 mg EC-18 dose or placebo Cohort 4 Placebo 4000 mg EC-18 dose or placebo
- Primary Outcome Measures
Name Time Method The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo. 30 days
- Secondary Outcome Measures
Name Time Method To determine the composite pharmacokinetic (PK) parameters of EC-18 following sngle oral doses. AUC0-t, AUC0-24, Cmax, Tmax, 48-hour time period. Predose [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 hours post dose AUC0-t: Area under the plasma drug concentration versus time curve from time zero to time t; AUC0-24: Area under the plasma concentration versus time curve from time zero to 24 hours after dosing, Cmax: Maximum observed plasma drug concentration; Tmax: Time of maximum drug concentration
Trial Locations
- Locations (1)
Carolina Phase I Clinical Research
🇺🇸Raleigh, North Carolina, United States