Chemotherapy-induced NeutropeniaPhase 1NCT02496143
A Safety and PK Study of EC-18 in Healthy Subjects
A Phase 1 study testing EC-18 in people with Chemotherapy-induced Neutropenia, run by Enzychem Lifesciences Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females of childbearing potential must use an acceptable birth control method throughout the study and for 14 days after the dose of study drug.
- Females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo-oophorectomy] or postmenopausal for >2 years) with a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
- Males willing to practice contraception (condom + spermicide) during the study and for 14 days after completion of the study, or who have a female partner using barrier or oral contraception during that timeframe.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
- Ability to understand and give informed consent and provide authorization for use of protected health information (Health Insurance Portability and Accountability Act).
- Willing and able to be confined to the research clinic as required by the protocol.
Who cannot join
- Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1.
- Clinically significant laboratory findings at the Screening Visit defined as the following:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin >1.5 x upper limit of normal (ULN)
- Blood urea nitrogen (BUN), creatinine >1.25 x ULN
- White blood cell (WBC) count <0.9 x lower limit of normal (LLN) or >1.1 x ULN
- Hemoglobin or hematocrit <0.9 x LLN or >1.1 x ULN
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- Platelet count <0.9 x LLN or >1.1 x ULN
- Glucose <0.9 x LLN or >1.25 x ULN
- Thyroid-stimulating hormone (TSH) <0.75 x LLN or >1.25 x ULN or any other laboratory, ECG, vital sign, or physical abnormality that, in the investigator's opinion, unfavorably increases the risk of study participation.
- Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.
- History of drug or alcohol abuse within the past 2 years.
- Females who are pregnant or intend to get pregnant over the next month.
- Positive urine pregnancy test at the Screening Visit or at admission to the research clinic on Day -1.
- Positive urine drug or breath alcohol test at the Screening Visit or at admission to the research clinic on Day -1. Subjects should be instructed not to drink alcohol within 12 hours of the screening assessment.
- Intake of alcohol within 72 hours prior to study drug administration or intake of grapefruit or Seville oranges within 7 days prior to the administration of study drug.
- Strenuous physical exercise within 48 hours prior to study drug administration.
- Administration of any over-the-counter medication, dietary supplements, or vitamins within 7 days prior to study drug administration. Excluded from this list is nondaily use of acetaminophen at doses of ≤2 grams over a 24-hour period.
- Administration of prescription drugs or herbal supplements within 14 days prior to study drug administration.
- -.Exposure to any investigational agent within 30 days prior to the Screening Visit.
- Any current medical illness, signs, or symptoms that, in the investigator's opinion, could adversely affect subject safety or study integrity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Phase I Clinical Research
Raleigh, North Carolina, 27612
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Administration of EC-18 in Healthy Subjects
The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
Read the detailed description
This will be a randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort of subjects will not occur until a review of the safety and tolerability data from the previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor together confirm the safety and tolerability of EC-18 given at that dose level.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- EC-18, Placebo
- Keywords
- Healthy Volunteers, Phase I, Placebo controlled, Single Ascending Dose, PK, Oral administration, Softgel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-18Drug
Also called EC-18 Softgel capsule
EC-18 will be supplied as 500 mg Softgel capsules. The study will include up to four sequential dose cohorts. Six subjects in each cohort will be randomized to receive EC-18: 500, 1000, 2000, or 4000 mg by oral administration of 1, 2, 4, and 8 EC-18 capsules, for Cohorts 1, 2, 3 or 4, respectively.
PlaceboDrug
Placebo will be supplied as Softgel capsules. The study will include up to four sequential dose cohorts. Two subjects in each cohort will be randomized to placebo and will receive 1, 2, 4 or 8 placebo capsules for Cohorts 1, 2, 3 or 4, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 500 mg EC-18 dose or placebo Receives: Drug: EC-18; Drug: Placebo |
| Cohort 2 | Experimental | 1000 mg EC-18 dose orplacebo Receives: Drug: EC-18; Drug: Placebo |
| Cohort 3 | Experimental | 2000 mg EC-18 dose or placebo Receives: Drug: EC-18; Drug: Placebo |
| Cohort 4 | Experimental | 4000 mg EC-18 dose or placebo Receives: Drug: EC-18; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo.
Measured: 30 days
Secondary outcomes (1)
To determine the composite pharmacokinetic (PK) parameters of EC-18 following sngle oral doses. AUC0-t, AUC0-24, Cmax, Tmax, 48-hour time period.
AUC0-t: Area under the plasma drug concentration versus time curve from time zero to time t; AUC0-24: Area under the plasma concentration versus time curve from time zero to 24 hours after dosing, Cmax: Maximum observed plasma drug concentration; Tmax: Time of maximum drug concentration
Measured: Predose [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 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.
- First posted14 Jul 2015 (estimated)
- Study startJul 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzychem Lifesciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Treva W Tyson, MD, Principal investigator, Wake Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496143
- Sponsor's protocol ID
- EC-18-001
- Status last verified
- Jan 2016
- First submitted
- 29 Jun 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Administration of EC-18 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02496143
- Acronym / sponsor ID
- EC-18-001
- Conditions
- Chemotherapy-induced Neutropenia
- Keywords
- Healthy Volunteers, Phase I, Placebo controlled, Single Ascending Dose, PK, Oral administration, Softgel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Enzychem Lifesciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
Detailed description
This will be a randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort of subjects will not occur until a review of the safety and tolerability data from the previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor together confirm the safety and tolerability of EC-18 given at that dose level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EC-18, Drug: Placebo500 mg EC-18 dose or placebo |
| Cohort 2 | Experimental | Drug: EC-18, Drug: Placebo1000 mg EC-18 dose orplacebo |
| Cohort 3 | Experimental | Drug: EC-18, Drug: Placebo2000 mg EC-18 dose or placebo |
| Cohort 4 | Experimental | Drug: EC-18, Drug: Placebo4000 mg EC-18 dose or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females of childbearing potential must use an acceptable birth control method throughout the study and for 14 days after the dose of study drug.
- Females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo-oophorectomy] or postmenopausal for >2 years) with a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
- Males willing to practice contraception (condom + spermicide) during the study and for 14 days after completion of the study, or who have a female partner using barrier or oral contraception during that timeframe.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
- Ability to understand and give informed consent and provide authorization for use of protected health information (Health Insurance Portability and Accountability Act).
Key exclusion criteria (20 listed)
- Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1.
- Clinically significant laboratory findings at the Screening Visit defined as the following:
- Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.
- History of drug or alcohol abuse within the past 2 years.
- Females who are pregnant or intend to get pregnant over the next month.
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: EC-18 Softgel capsuleEC-18 will be supplied as 500 mg Softgel capsules. The study will include up to four sequential dose cohorts. Six subjects in each cohort will be randomized to receive EC-18: 500, 1000, 2000, or 4000 mg by oral administration of 1, 2, 4, and 8 EC-18 capsules, for Cohorts 1, 2, 3 or 4, respectively. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboPlacebo will be supplied as Softgel capsules. The study will include up to four sequential dose cohorts. Two subjects in each cohort will be randomized to placebo and will receive 1, 2, 4 or 8 placebo capsules for Cohorts 1, 2, 3 or 4, respectively. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo.
Time frame: 30 days
1 secondary outcome
To determine the composite pharmacokinetic (PK) parameters of EC-18 following sngle oral doses. AUC0-t, AUC0-24, Cmax, Tmax, 48-hour time period.
Time frame: Predose [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 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 11 Jan 2016.
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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.
Treva W Tyson, MD principal investigator
Wake Research Associates
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 United States.
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 20 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 11 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 United States. 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?
The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo. (time frame: 30 days). 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 11 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.