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

NCT02700360 | Completed Phase 1

• 1 other identifier: EC18-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapy-Induced Neutropenia

Keywords

EC-18; Hematology; Cancer; Neutropenia

Outcome Measures

Primary Outcomes (5)

• evaluate safety and tolerability: Number and severity of ADRs monitoring such as subjective, objective symptom(change value from baseline)

  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)

  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)

  screening, Day-3(Day5), Day3(Day10) and Day15(follow-up)

• evaluate safety and tolerability: clinical laboratory test(change value from baseline)

  screening, Day-3(Day5), Day3(Day10) and Day15(follow-up)

• evaluate safety and tolerability: EKG(change value from baseline)

  screening, Day-3(Day5) and Day15(follow-up)

Secondary Outcomes (7)

• evaluate pharmacokinetics: Cmax

  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

  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

  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

  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

  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

Study Arms (6)

Part 1(1,000mg dose): group 1

EXPERIMENTAL

period 1: EC-18 1,000 mg(500 mg/cap, 2 capsules) once daily, after high-fat diet intake; period 2: EC-18 1,000 mg(500 mg/cap, 2 capsules) once daily, on an empty stomach; cross-over period: 7 days

Dietary Supplement: high-fat diet; Drug: EC-18

Part 1(1,000mg dose): group 2

EXPERIMENTAL

period 1: EC-18 1,000 mg(500 mg/cap, 2 capsules) once daily, on an empty stomach; period 2: EC-18 1,000 mg(500 mg/cap, 2 capsules) once daily, after high-fat diet intake; cross-over period: 7 days

Dietary Supplement: high-fat diet; Drug: EC-18

Part 2(500mg dose): group 3

EXPERIMENTAL

period 1: EC-18 500 mg(500 mg/cap, 1 capsule) once daily, after high-fat diet intake; period 2: EC-18 500 mg(500 mg/cap, 1 capsule) once daily, on an empty stomach; cross-over period: 7 days

Dietary Supplement: high-fat diet; Drug: EC-18

Part 2(500mg dose): group 4

EXPERIMENTAL

period 1: EC-18 500 mg(500 mg/cap, 1 capsule) once daily, on an empty stomach; period 2: EC-18 500 mg(500 mg/cap, 1 capsule) once daily, after high-fat diet intake; cross-over period: 7 days

Dietary Supplement: high-fat diet; Drug: EC-18

Part 2(2,000mg dose): group 5

EXPERIMENTAL

period 1: EC-18 2,000 mg(500 mg/cap, 4 capsules) once daily, after high-fat diet intake; period 2: EC-18 2,000 mg(500 mg/cap, 4 capsules) once daily, on an empty stomach; cross-over period: 7 days

Dietary Supplement: high-fat diet; Drug: EC-18

Part 2(2,000mg dose): group 6

EXPERIMENTAL

period 1: EC-18 2,000 mg(500 mg/cap, 4 capsules) once daily, on an empty stomach; period 2: EC-18 2,000 mg(500 mg/cap, 4 capsule) once daily, after high-fat diet intake; cross-over period: 7 days

Dietary Supplement: high-fat diet; Drug: EC-18

Interventions

high-fat diet DIETARY_SUPPLEMENT

This trial is conducted as a randomized, open-label, single -dose, crossover, phase I to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18. EC-18 is given at an oral, once daily in condition of empty stomach and a high fat diet(900\~1,000 kcal, contains 50\~60%lipid).This trial is divided into Part 1(1,000mg dose) and Part 2(500mg dose and 2,000mg dose), 12 subjects are included in each dose and cross-over period is 7 days. After Part 1 study, If primary PK parameters of EC-18 is affected by food and AEs meeting study discontinuation criteria are not reported, Part 2 will proceed in consecutive order with registering new subjects.

Part 1(1,000mg dose): group 1; Part 1(1,000mg dose): group 2; Part 2(2,000mg dose): group 5; Part 2(2,000mg dose): group 6; Part 2(500mg dose): group 3; Part 2(500mg dose): group 4

EC-18 DRUG

This trial is conducted as a randomized, open-label, single -dose, crossover, phase I to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18. EC-18 is given at an oral, once daily in condition of empty stomach and a high fat diet(900\~1,000 kcal, contains 50\~60%lipid).This trial is divided into Part 1(1,000mg dose) and Part 2(500mg dose and 2,000mg dose), 12 subjects are included in each dose and cross-over period is 7 days. After Part 1 study, If primary PK parameters of EC-18 is affected by food and AEs meeting study discontinuation criteria are not reported, Part 2 will proceed in consecutive order with registering new subjects

Also known as: EC18 Soft-capsule

Part 1(1,000mg dose): group 1; Part 1(1,000mg dose): group 2; Part 2(2,000mg dose): group 5; Part 2(2,000mg dose): group 6; Part 2(500mg dose): group 3; Part 2(500mg dose): group 4

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
• body weight: ≥ 55kg(male), ≥ 50kg(female)
• BMI: 18.5 kg/m2 ≦ BMI \< 25.0 kg/m2 \[BMI(body mass index) = Body weight (kg)/\[height (m)\]2 \]
• in female subjects, the result of serum β-hCG pregnancy test comes out negative at screening, urine β-hCG test comes out negative before taking medication during the period set by this protocol have to be included one of the below conditions.
• postmenopausal(no natural menstruation at least 2 years)
• surgically sterile(hysterectomy or bilateral ovariotomy, tubal ligation or sterile condition by other ways)
• sterility of male partner before screening(proof the azoospermia after vasectomy), and this is the only partner of the subject.
• agree with using a proper and continuous method of contraception start on 14 days(at least) before the1st IND administration and for 28 days(at least) after the last IND administration
• proper contraception means physical barrier method including condom, contraceptive diaphragm or cervix cap, do not use a hormones including contraceptive or oral contraceptive during the study.
• if the male have a sex life with childbearing aged female, maintain proper contraception during the study and for 28 days after the last IND administration, agree with "do not donate the sperm"(if the female partner is infertility, above contraceptions are not necessary)
• Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial

You may not qualify if:

• Hypersensitivity to a drug containing an ingredient of the investigational product(EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity
• Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records
• Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records
• Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history
• (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis
• Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.

Sponsors & Collaborators

• Enzychem Lifesciences Corporation: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Neoplasms; Neutropenia

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Min-Soo Park, Professor

  Yonsei University Health System, Severance Hospital (Seoul)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: March 7, 2016
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 15, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)