Chemotherapy-Induced NeutropeniaPhase 1NCT02700360
Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers
A Phase 1 study testing high-fat diet and EC-18 in people with Chemotherapy-Induced Neutropenia, run by Enzychem Lifesciences Corporation at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-Induced Neutropenia
- What is being tested?
- high-fat diet and EC-18
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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 Volunteers
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
Read the 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
- Being tested
- high-fat diet, EC-18
- Keywords
- EC-18, Hematology, Cancer, Neutropenia
- Medical subject headings
- Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-fat dietDietary 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-18Drug
Also called EC18 Soft-capsule
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: high-fat diet; Drug: EC-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate safety and tolerability: Number and severity of ADRs monitoring such as subjective, objective symptom(change value from baseline)
Measured: 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)
Measured: 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)
Measured: screening, Day-3(Day5), Day3(Day10) and Day15(follow-up)
evaluate safety and tolerability: clinical laboratory test(change value from baseline)
Measured: screening, Day-3(Day5), Day3(Day10) and Day15(follow-up)
evaluate safety and tolerability: EKG(change value from baseline)
Measured: screening, Day-3(Day5) and Day15(follow-up)
Secondary outcomes (7)
evaluate pharmacokinetics: Cmax
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzychem Lifesciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Soo Park, Professor, Principal investigator, Yonsei University Health System, Severance Hospital (Seoul)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700360
- Sponsor's protocol ID
- EC18-102
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Volunteers
- ClinicalTrials.gov ID
- NCT02700360
- Acronym / sponsor ID
- EC18-102
- Conditions
- Chemotherapy-Induced Neutropenia
- Keywords
- EC-18, Hematology, Cancer, Neutropenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Enzychem Lifesciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1(1,000mg dose): group 1 | Experimental | Dietary Supplement: high-fat diet, Drug: EC-18period 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 |
| Part 1(1,000mg dose): group 2 | Experimental | Dietary Supplement: high-fat diet, Drug: EC-18period 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 |
| Part 2(500mg dose): group 3 | Experimental | Dietary Supplement: high-fat diet, Drug: EC-18period 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 |
| Part 2(500mg dose): group 4 | Experimental | Dietary Supplement: high-fat diet, Drug: EC-18period 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 |
| Part 2(2,000mg dose): group 5 | Experimental | Dietary Supplement: high-fat diet, Drug: EC-18period 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 |
| Part 2(2,000mg dose): group 6 | Experimental | Dietary Supplement: high-fat diet, Drug: EC-18period 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 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-fat dietThis 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. | Dietary supplement | 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-18Also: EC18 Soft-capsuleThis 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 | Drug | 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 |
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)
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Soo Park, Professor principal investigator
Yonsei University Health System, Severance Hospital (Seoul)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing high-fat diet and EC-18 in people with Chemotherapy-Induced Neutropenia, run by Enzychem Lifesciences Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.