a safety and pk study of ec-18 in healthy subjects

Conditions: Chemotherapy-induced Neutropenia

Summary: the purpose of this study is to determine if ec-18 is safe and tolerable in healthy subjects.

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.

Eligibility 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 \ 1.1 x uln * hemoglobin or hematocrit \ 1.1 x uln * platelet count \ 1.1 x uln * glucose \ 1.25 x uln * thyroid-stimulating hormone (tsh) \ 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.

Keywords: healthy volunteers phase i placebo controlled single ascending dose pk oral administration softgel