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

Completed · Phase 1 · Has a placebo group

Conditions studied: Chemotherapy-induced Neutropenia

In brief

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

Key facts

Study ID

NCT02496143

Run by

Enzychem Lifesciences Corporation

People needed

33

Starts

2015-07-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Carolina Phase I Clinical Research — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.