Clinical Trial: Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 After Oral Administration in Healthy

Brief Summary: A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral Administration in Healthy Volunteers

Detailed Summary:

In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of action of improving neutropenia by promoting neutrophil production from hematopoietic stem cells and at the same time, efficiently controlling STAT6/Complement 3(C 3), suggesting its potential to be developed as an orally administered new drug for treatment of neutropenia resulting from decreased neutrophils caused by administration of an anticancer agent.

This study is a randomized, open-Label, single -dose, crossover, phase I clinical trial to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18 after oral administration in healthy volunteers


Sponsor: Enzychem Lifesciences Corporation

Current Primary Outcome:

  • evaluate safety and tolerability: Number and severity of ADRs monitoring such as subjective, objective symptom(change value from baseline) [ Time Frame: Day-3(Day5), Day-2(Day6), Day-1(Day7), Day1(Day8), Day2(Day9), D3(Day10) and Day15(follow-up) ]
  • evaluate safety and tolerability:vital sign(change value from baseline) [ Time Frame: screening, 0(before medication) of Day-3(Day5), Day-2(Day6), Day-1(Day7), Day1(Day8), after medication 4, 12, 24, 36, 48hours and Day15(Follow-up) ]
  • evaluate safety and tolerability: physical examination(change value from baseline) [ Time Frame: screening, Day-3(Day5), Day3(Day10) and Day15(follow-up) ]
  • evaluate safety and tolerability: clinical laboratory test(change value from baseline) [ Time Frame: screening, Day-3(Day5), Day3(Day10) and Day15(follow-up) ]
  • evaluate safety and tolerability: EKG(change value from baseline) [ Time Frame: screening, Day-3(Day5) and Day15(follow-up) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • evaluate pharmacokinetics: Cmax [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]
  • evaluate pharmacokinetics: AUClas [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]
  • evaluate pharmacokinetics: tmax [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]
  • evaluate pharmacokinetics: AUCinf [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]
  • evaluate pharmacokinetics: t1/2 [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]
  • evaluate pharmacokinetics: CL/F [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]
  • evaluate pharmacokinetics: Vd/F [ Time Frame: 33 times per each period, total 66 times; Day-2(Day6):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours; Day1(Day8):0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48hours ]


Original Secondary Outcome: Same as current

Information By: Enzychem Lifesciences Corporation

Dates:
Date Received: January 20, 2016
Date Started: August 2015
Date Completion:
Last Updated: March 13, 2016
Last Verified: March 2016