Chemotherapy-Induced NeutropeniaPhase 1NCT02532712

Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers

A Phase 1 study testing EC-18 in people with Chemotherapy-Induced Neutropenia, run by Enzychem Lifesciences Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult… Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Chemotherapy-Induced Neutropenia
What is being tested?: EC-18
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteSouth Korea
Study dates: Mar 2015to Dec 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
Body weight ≥ 50 kg, and calculated BMI in the range of 18.5 kg/m2 ≤ BMI < 25.0 kg/m2 ☞ BMI(body mass index) = Body weight (kg)/[height (m)]2
No inherited or chronic disease and pathologic symptoms or findings from internal examinations
Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug
Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial
Consent to practice medically acceptable contraception during the 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

Other trials in South Korea

About this study

Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male 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(C3), 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.

Conditions: Chemotherapy-Induced Neutropenia
Being tested: EC-18, Placebo
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.

EC-18Drug
Also called EC18 Soft-capsule
EC-18 Soft-capsule (500mg/1 capsule)
PlaceboDrug
Also called Placebo for EC-18 (Sofe-capsule)
Placebo with same shape and size

Study groups in NCT02532712
Study group	Role	What they receive
Single dose group-Group 1-Experimental	Experimental	Single dose, 500mg of Study drug(EC-18) Receives: Drug: EC-18
Single dose group-Group 1-Placebo	Placebo comparator	Single dose, 500mg of Placebo Receives: Drug: Placebo
Single dose group-Group 2-Experimental	Experimental	Single dose, 1000mg of Study drug(EC-18) Receives: Drug: EC-18
Single dose group-Group 2-Placebo	Placebo comparator	Single dose, 1000mg of Placebo Receives: Drug: Placebo
Single dose group-Group 3-Experimental	Experimental	Single dose, 2000mg of Study drug (EC-18) Receives: Drug: EC-18
Single dose group-Group 3-Placebo	Placebo comparator	Single dose, 2000mg of Placebo Receives: Drug: Placebo
Single dose group-Group 4-Experimental	Experimental	Single dose, 4000mg of Study drug (EC-18) Receives: Drug: EC-18
Single dose group-Group 4-Placebo	Placebo comparator	Single dose, 4000mg of Placebo Receives: Drug: Placebo
Multiple dose group-Group 1-Experimental	Experimental	Multiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days Receives: Drug: EC-18
Multiple dose group-Group 1-Placebo	Placebo comparator	Multiple dose, Placebo 500mg, Once daily, for 14 days Receives: Drug: Placebo
Multiple dose group-Group 2-Experimental	Experimental	Multiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days Receives: Drug: EC-18
Multiple dose group-Group 2-Placebo	Placebo comparator	Multiple dose, Placebo 1000mg, Once daily, for 14 days Receives: Drug: Placebo
Multiple dose group-Group 3-Experimental	Experimental	Multiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days Receives: Drug: EC-18
Multiple dose group-Group 3-Placebo	Placebo comparator	Multiple dose, Placebo 2000mg, Once daily, for 14 days Receives: Drug: Placebo
Multiple dose group-Group 4-Experimental	Experimental	Multiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days Receives: Drug: EC-18
Multiple dose group-Group 4-Placebo	Placebo comparator	Multiple dose, Placebo 4000mg, Once daily, for 14 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

No. and severity of Adverse event as a Measure of Safety and Tolerability
Measured: From date of D-1 until Follow-up visit: up to 30 days
Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability
Measured: From date of screening until Follow-up visit: up to 60 days

Secondary outcomes (17)

Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: Tmax (Time of maximum drug concentration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUClast (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUCinf (Area under the plasma concentration-time curve from time zero extrapolated to the infinite time)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: t1/2 (Half-life)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax,ss (Maximum (peak) steady-state plasma drug concentration during a dosage interval)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmin,ss (Minimum steady-state plasma drug concentration during a dosage interval)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cavg,ss (Average steady-state plasma drug concentration during multiple-dose administration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Fluctuation
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: t1/2 (half-life)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCτ (Area under the plasma concentration-time curve from time zero to time t)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCinf (Area under the plasma concentration-time curve from time zero to infinity)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax (Maximum (peak) plasma drug concentration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Tmax (Time to reach maximum (peak) plasma concentration following drug
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Accumulation index
Measured: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Dec 2015

First posted26 Aug 2015 (estimated)
Study startMar 2015
Primary completionDec 2015
Study completionDec 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02532712
Sponsor's protocol ID: EC-18-101
Status last verified: Jan 2016
First submitted: 4 Aug 2015
Last updated: 27 Jan 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided: I will update the status when it is decided.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
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Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 2
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
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All Chemotherapy-Induced Neutropenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02532712
Acronym / sponsor ID: EC-18-101
Conditions: Chemotherapy-Induced Neutropenia
Keywords: EC-18, Hematology, Cancer, Neutropenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Enzychem Lifesciences CorporationIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 26 Aug 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 16

Arm	Type	Receives
Single dose group-Group 1-Experimental	Experimental	Drug: EC-18Single dose, 500mg of Study drug(EC-18)
Single dose group-Group 1-Placebo	Placebo comparator	Drug: PlaceboSingle dose, 500mg of Placebo
Single dose group-Group 2-Experimental	Experimental	Drug: EC-18Single dose, 1000mg of Study drug(EC-18)
Single dose group-Group 2-Placebo	Placebo comparator	Drug: PlaceboSingle dose, 1000mg of Placebo
Single dose group-Group 3-Experimental	Experimental	Drug: EC-18Single dose, 2000mg of Study drug (EC-18)
Single dose group-Group 3-Placebo	Placebo comparator	Drug: PlaceboSingle dose, 2000mg of Placebo
Single dose group-Group 4-Experimental	Experimental	Drug: EC-18Single dose, 4000mg of Study drug (EC-18)
Single dose group-Group 4-Placebo	Placebo comparator	Drug: PlaceboSingle dose, 4000mg of Placebo
Multiple dose group-Group 1-Experimental	Experimental	Drug: EC-18Multiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days
Multiple dose group-Group 1-Placebo	Placebo comparator	Drug: PlaceboMultiple dose, Placebo 500mg, Once daily, for 14 days
Multiple dose group-Group 2-Experimental	Experimental	Drug: EC-18Multiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days
Multiple dose group-Group 2-Placebo	Placebo comparator	Drug: PlaceboMultiple dose, Placebo 1000mg, Once daily, for 14 days
Multiple dose group-Group 3-Experimental	Experimental	Drug: EC-18Multiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days
Multiple dose group-Group 3-Placebo	Placebo comparator	Drug: PlaceboMultiple dose, Placebo 2000mg, Once daily, for 14 days
Multiple dose group-Group 4-Experimental	Experimental	Drug: EC-18Multiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days
Multiple dose group-Group 4-Placebo	Placebo comparator	Drug: PlaceboMultiple dose, Placebo 4000mg, Once daily, for 14 days

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
Body weight ≥ 50 kg, and calculated BMI in the range of 18.5 kg/m2 ≤ BMI < 25.0 kg/m2 ☞ BMI(body mass index) = Body weight (kg)/[height (m)]2
No inherited or chronic disease and pathologic symptoms or findings from internal examinations
Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug
Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial

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
EC-18Also: EC18 Soft-capsuleEC-18 Soft-capsule (500mg/1 capsule)	Drug	Multiple dose group-Group 1-Experimental, Multiple dose group-Group 2-Experimental, Multiple dose group-Group 3-Experimental, Multiple dose group-Group 4-Experimental, Single dose group-Group 1-Experimental, Single dose group-Group 2-Experimental, Single dose group-Group 3-Experimental, Single dose group-Group 4-Experimental
PlaceboAlso: Placebo for EC-18 (Sofe-capsule)Placebo with same shape and size	Drug	Multiple dose group-Group 1-Placebo, Multiple dose group-Group 2-Placebo, Multiple dose group-Group 3-Placebo, Multiple dose group-Group 4-Placebo, Single dose group-Group 1-Placebo, Single dose group-Group 2-Placebo, Single dose group-Group 3-Placebo, Single dose group-Group 4-Placebo

Primary outcome

No. and severity of Adverse event as a Measure of Safety and Tolerability
Time frame: From date of D-1 until Follow-up visit: up to 30 days
Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability
Time frame: From date of screening until Follow-up visit: up to 60 days

17 secondary outcomes

Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: Tmax (Time of maximum drug concentration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUClast (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUCinf (Area under the plasma concentration-time curve from time zero extrapolated to the infinite time)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: t1/2 (Half-life)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax,ss (Maximum (peak) steady-state plasma drug concentration during a dosage interval)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmin,ss (Minimum steady-state plasma drug concentration during a dosage interval)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cavg,ss (Average steady-state plasma drug concentration during multiple-dose administration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Fluctuation
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: t1/2 (half-life)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCτ (Area under the plasma concentration-time curve from time zero to time t)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCinf (Area under the plasma concentration-time curve from time zero to infinity)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax (Maximum (peak) plasma drug concentration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Tmax (Time to reach maximum (peak) plasma concentration following drug
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Accumulation index
Time frame: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose

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 27 Jan 2016.
Individual participant dataSharing planned: Undecided. I will update the status when it is decided.

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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 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 6 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 27 Jan 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. Some participants in this study may receive a placebo. 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?

No. and severity of Adverse event as a Measure of Safety and Tolerability (time frame: From date of D-1 until Follow-up visit: up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02532712.

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 27 Jan 2016.