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

NCT ID: NCT02700360

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-10-31

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 Description

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

Conditions

Chemotherapy-Induced Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

high-fat diet

Intervention Type: 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.

EC-18

Intervention Type: 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

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

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

Group Type: EXPERIMENTAL

high-fat diet

Intervention Type: 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.

EC-18

Intervention Type: 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

Part 2(500mg dose): group 3

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

Group Type: EXPERIMENTAL

high-fat diet

Intervention Type: 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.

EC-18

Intervention Type: 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

Part 2(500mg dose): group 4

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

Group Type: EXPERIMENTAL

high-fat diet

Intervention Type: 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.

EC-18

Intervention Type: 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

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

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

Group Type: EXPERIMENTAL

high-fat diet

Intervention Type: 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.

EC-18

Intervention Type: 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

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

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

Group Type: EXPERIMENTAL

high-fat diet

Intervention Type: 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.

EC-18

Intervention Type: 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

Interventions

high-fat diet

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.

Intervention Type: DIETARY_SUPPLEMENT

EC-18

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

Intervention Type: DRUG

Other Intervention Names

EC18 Soft-capsule

Eligibility Criteria

Inclusion Criteria

1. Healthy adult aged between 19 and 45 years, inclusive, at the time of providing the informed consent form

2. body weight: ≥ 55kg(male), ≥ 50kg(female)

3. BMI: 18.5 kg/m2 ≦ BMI < 25.0 kg/m2 [BMI(body mass index) = Body weight (kg)/[height (m)]2 ]

4. 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.

5. 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)

6. Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial

Exclusion Criteria

1. 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

2. Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records

3. 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

4. Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history

5. (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

6. 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzychem Lifesciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-Soo Park, Professor

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Severance Hospital (Seoul)

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

EC18-102

Identifier Type: -

Identifier Source: org_study_id