Healthy SubjectsPhase 1NCT06089837
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Oral EC5026 in Healthy Subjects
A Phase 1 study testing EC5026 oral tablet in people with Healthy Subjects, run by EicOsis Human Health Inc. at 1 site in New Zealand.
Trial summary
EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Two Phase 1a studies - a Phase 1a single ascending dose (SAD) study and a Phase 1a fed-fasted study - have been conducted, evaluating the safety, tolerability, PK, and food effects of single… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- EC5026 oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNew Zealand
- Study dates
- 28 Nov 2023to 12 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each subject must meet all of the following criteria to be enrolled in this study:
- Male and female subjects must be 18 years or older.
- Subjects must be willing to provide written informed consent to participate in the study.
- Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.
- Subjects must be willing to remain in confinement at the clinical study unit for up to 8.5 consecutive days and to return to the unit as specified for additional blood tests and safety evaluations during the study period.
- Subjects must have a body mass index (BMI) of 19-32 kg/m2. Participants with a BMI below 19 kg/m2 may be enrolled at the Investigator's discretion.
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- Subjects must have a systolic blood pressure (BP) of 90-160 mmHg, diastolic BP of 50-90 mmHg, and resting HR of 40-100 beats per min without medication at Screening.
- Subjects must have clinical chemistry values for electrolytes, alkaline phosphatase (ALP), alanine aminotransferase (ALT <1.5x ULN), aspartate aminotransferase (AST, <1.5x ULN), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), creatinine, bilirubin (<2x ULN), and urea that are within the normal range without medication or not clinically significant for a healthy population in the opinion of the Investigator at Screening. Renal clearance measured by eGFR must be normal (≥80 mL/min). Urinalysis values must be within normal limits or not clinically significant for a healthy population in the opinion of the Investigator at Screening. Laboratory analyses and urinalysis may be repeated once at the Investigator's discretion to confirm the accuracy of the results.
- Subjects must have an early morning (drawn seated between 0600 am and 0800 am) serum cortisol level >5 mcg/dL (>137.9 nmol/L) and early morning adrenocorticotropic hormone (ACTH) and aldosterone levels within the normal range at screening. Randomization will be conditional to a normal cortisol response to ACTH stimulation during screening [serum cortisol level ≥16 mcg/dL (≥440 nmol/L) after IM ACTH injection].
- Subjects must be non-smokers or previous smokers who have not smoked within the previous 6 months prior to Screening.
- Male participants must use, from randomization until at least 2 months after the last dose, a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), e.g.: sterilisation (e.g., vasectomy), and/or barrier forms of contraception, including condoms (external or internal) and diaphragm ('cap').
- Male subjects must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
- Female subjects must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after clinic discharge. Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and/or barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants/Participant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Subjects who have used any non-study medication(s), including low-dose aspirin for cardiovascular prophylaxis, within 1 week before administration of study drug.
- Subjects who have used chemotherapy agents, or who have a personal history of cancer or metastatic cancer in first degree relatives suggestive of elevated cancer risk in the opinion of the investigator, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening.
- Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.
- Subjects with a presence or history of peripheral edema within the past 5 years, with the exception of that caused by trauma.
- Subjects with a history of disorders of the HPA or HPG axis.
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- Subjects with a history of congestive heart failure.
- Subjects who have used (within 30 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are cytochrome P450 (CYP450) inducers or inhibitors (e.g., cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, or clarithromycin).
- Subjects who have used (within 30 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are known to modulate drug metabolizing enzymes (e.g., St. John's wort, grapefruit juice).
- Subjects with difficulty in swallowing oral medications.
- Subjects with serious psychosocial comorbidities as determined by the Investigator.
- Subjects with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit for up to 8.5 days.
- Subjects with a positive drug or alcohol test during Screening and/or admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator).
- Subjects who have used any other investigational drug within 1 month prior to Screening.
- Subjects who have used any over-the-counter medications within 2 weeks of randomization, or paracetamol or ibuprofen within 7 days of randomization
- Subjects who have donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to randomization.
- Subjects with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or renal, hepatic, or coagulant disorder within 1 month prior to enrollment.
- Subjects with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).
- Subjects with a cumulative exposure to any oral or inhaled glucocorticoid of more than 1 week duration within 6 months prior to randomization.
- Subjects with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID-19) at the time of Screening.
- Subjects with confirmed moderate-severe COVID-19 within 2 months of randomization or with confirmed asymptomatic or mild COVID-19 within 4 weeks of randomization.
- Subjects who have received a COVID-19 vaccine within 4 weeks of randomization or are planning on receiving it during the study duration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Multiple Ascending Dose (MAD) Study of EC5026 in Healthy Volunteers
EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Two Phase 1a studies - a Phase 1a single ascending dose (SAD) study and a Phase 1a fed-fasted study - have been conducted, evaluating the safety, tolerability, PK, and food effects of single oral doses of EC5026 ranging 0.5 to 24 mg. The present study will evaluate the safety, tolerability, and PK of 2 sequential ascending dose regimens of EC5026, administered once daily for 7 consecutive days, in healthy volunteers.
Read the detailed description
This is double-blind, randomized, placebo-controlled Phase 1b multiple ascending dose (MAD) study to investigate the safety, tolerability, and pharmacokinetics (PK) of 2 sequential dose regimens of oral EC5026 in healthy male and female subjects.
EC5026 is an inhibitor of the soluble Epoxide Hydrolase (sEH) enzyme developed as a first-in-class analgesic for the treatment of pain. sEH is an enzyme that is downstream in the cytochrome P450 (CYP) pathway of the arachidonic acid (AA) cascade. The sEH enzyme is responsible of metabolizing a class of epoxy-fatty acids known as epoxyeicosatrienoic acids (EETs), which are potent, naturally occurring analgesics. EETs are produced at high concentrations in areas of tissue damage and inflammation, but are rapidly metabolized by the sEH enzyme into inactive compounds. Effective inhibition of sEH activity prolongs the ability of EETs to exert their analgesic activity.
This Phase 1b MAD study will be enrolling 16 healthy male and female subjects 18 years and older. EC5026 and placebo will be administered orally in tablets. Study drug (active or placebo) will be administered as a single oral dose daily, for 7 consecutive days. Subjects assigned to the active drug will receive a single loading dose on Day 1 and a single maintenance dose on Days 2-7. The dose regimens to be assessed in this Phase 1b trial correspond to the following loading dose and maintenance dose pairs: 4 mg/2 mg (Cohort 1, total cumulative 7-day oral dose of 16 mg), and 8 mg/4 mg (Cohort 2, total cumulative 7-day oral dose of 32 mg).
- Conditions
- Healthy Subjects
- Being tested
- EC5026 oral tablet, Placebo oral tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC5026 oral tabletDrug
2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days.
Oral doses of EC5026 tested in each cohort:
4 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 (Cohort 1) 8 mg loading dose on Day 1 / 4 mg Maintenance dose on Days 2-7 (Cohort 2)
Placebo oral tabletDrug
2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days. Subject assigned to the Placebo Arm will receive 7 days of matching placebo oral tablets in each Cohort.
| Study group | Role | What they receive |
|---|---|---|
| EC5026 | Experimental | Multiple Ascending Doses of oral EC5026 Receives: Drug: EC5026 oral tablet |
| Placebo | Experimental | Single doses of matching oral placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]
All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities will be used to code all AEs.
Measured: 30 days
Dose-related effects on electrocardiographic QTc interval (concentration QTc analysis)
Study participants will be wearing a ECG-Holter monitoring during the 7 days of dosing with study drug (EC5026 or placebo). ECG extractions will be performed concurrently with PK timepoints for concentration QTc analysis.
Measured: 7 days
Changes-from-baseline in electrocardiographic time intervals
Study participants will be wearing a ECG-Holter monitoring during the 7 days of dosing with study drug (EC5026 or placebo). ECG extractions will be performed concurrently with PK timepoints. Assessments will include evaluating changes-from-baseline heart rate (HR), PR interval, QRS interval, and QTc interval within the Holter ECG recording. All intervals are measured in time (msec).
Measured: 7 days
Area under the plasma concentration versus time curve (AUC) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Maximum observed plasma concentration (Cmax) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Time to maximum observed plasma concentration (Tmax) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Terminal elimination rate constant in plasma (Kel) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Terminal phase half-life in plasma (t1/2) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Apparent total body clearance (CL/F) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Apparent volume of distribution based on the terminal elimination rate constant in plasma (Vz/F) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 30 days
Renal clearance (CLR) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 7 days
Amount of drug excreted unchanged in urine (Ae) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 7 days
Fraction of eliminated dose in urine (Fe%) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Standard noncompartmental methods will be used.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start28 Nov 2023
- Primary completion13 Mar 2024
- Study completion12 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- EicOsis Human Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cory D Sellwood, MBChB, Principal investigator, New Zealand Clinical ResearchWilliam K Schmidt, PhD, Study director, EicOsis Human Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089837
- Sponsor's protocol ID
- EC5026-1-02
- Status last verified
- Jan 2025
- First submitted
- 12 Oct 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multiple Ascending Dose (MAD) Study of EC5026 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06089837
- Acronym / sponsor ID
- EC5026-1-02
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EicOsis Human Health Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 12 May 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- 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.
EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Two Phase 1a studies - a Phase 1a single ascending dose (SAD) study and a Phase 1a fed-fasted study - have been conducted, evaluating the safety, tolerability, PK, and food effects of single oral doses of EC5026 ranging 0.5 to 24 mg. The present study will evaluate the safety, tolerability, and PK of 2 sequential ascending dose regimens of EC5026, administered once daily for 7 consecutive days, in healthy volunteers.
Detailed description
This is double-blind, randomized, placebo-controlled Phase 1b multiple ascending dose (MAD) study to investigate the safety, tolerability, and pharmacokinetics (PK) of 2 sequential dose regimens of oral EC5026 in healthy male and female subjects.
EC5026 is an inhibitor of the soluble Epoxide Hydrolase (sEH) enzyme developed as a first-in-class analgesic for the treatment of pain. sEH is an enzyme that is downstream in the cytochrome P450 (CYP) pathway of the arachidonic acid (AA) cascade. The sEH enzyme is responsible of metabolizing a class of epoxy-fatty acids known as epoxyeicosatrienoic acids (EETs), which are potent, naturally occurring analgesics. EETs are produced at high concentrations in areas of tissue damage and inflammation, but are rapidly metabolized by the sEH enzyme into inactive compounds. Effective inhibition of sEH activity prolongs the ability of EETs to exert their analgesic activity.
This Phase 1b MAD study will be enrolling 16 healthy male and female subjects 18 years and older. EC5026 and placebo will be administered orally in tablets. Study drug (active or placebo) will be administered as a single oral dose daily, for 7 consecutive days. Subjects assigned to the active drug will receive a single loading dose on Day 1 and a single maintenance dose on Days 2-7. The dose regimens to be assessed in this Phase 1b trial correspond to the following loading dose and maintenance dose pairs: 4 mg/2 mg (Cohort 1, total cumulative 7-day oral dose of 16 mg), and 8 mg/4 mg (Cohort 2, total cumulative 7-day oral dose of 32 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC5026 | Experimental | Drug: EC5026 oral tabletMultiple Ascending Doses of oral EC5026 |
| Placebo | Experimental | Drug: Placebo oral tabletSingle doses of matching oral placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female subjects must be 18 years or older.
- Subjects must be willing to provide written informed consent to participate in the study.
- Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.
- Subjects must be willing to remain in confinement at the clinical study unit for up to 8.5 consecutive days and to return to the unit as specified for additional blood tests and safety evaluations during the study period.
- Subjects must have a body mass index (BMI) of 19-32 kg/m2. Participants with a BMI below 19 kg/m2 may be enrolled at the Investigator's discretion.
Key exclusion criteria (22 listed)
- Subjects who have used any non-study medication(s), including low-dose aspirin for cardiovascular prophylaxis, within 1 week before administration of study drug.
- Subjects who have used chemotherapy agents, or who have a personal history of cancer or metastatic cancer in first degree relatives suggestive of elevated cancer risk in the opinion of the investigator, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening.
- Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.
- Subjects with a presence or history of peripheral edema within the past 5 years, with the exception of that caused by trauma.
- Subjects with a history of disorders of the HPA or HPG axis.
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 |
|---|---|---|
| EC5026 oral tablet2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days. Oral doses of EC5026 tested in each cohort: 4 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 (Cohort 1) 8 mg loading dose on Day 1 / 4 mg Maintenance dose on Days 2-7 (Cohort 2) | Drug | EC5026 |
| Placebo oral tablet2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days. Subject assigned to the Placebo Arm will receive 7 days of matching placebo oral tablets in each Cohort. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]
Time frame: 30 days
All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities will be used to code all AEs.
Dose-related effects on electrocardiographic QTc interval (concentration QTc analysis)
Time frame: 7 days
Study participants will be wearing a ECG-Holter monitoring during the 7 days of dosing with study drug (EC5026 or placebo). ECG extractions will be performed concurrently with PK timepoints for concentration QTc analysis.
Changes-from-baseline in electrocardiographic time intervals
Time frame: 7 days
Study participants will be wearing a ECG-Holter monitoring during the 7 days of dosing with study drug (EC5026 or placebo). ECG extractions will be performed concurrently with PK timepoints. Assessments will include evaluating changes-from-baseline heart rate (HR), PR interval, QRS interval, and QTc interval within the Holter ECG recording. All intervals are measured in time (msec).
Area under the plasma concentration versus time curve (AUC) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Maximum observed plasma concentration (Cmax) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Time to maximum observed plasma concentration (Tmax) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Terminal elimination rate constant in plasma (Kel) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Terminal phase half-life in plasma (t1/2) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Apparent total body clearance (CL/F) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Apparent volume of distribution based on the terminal elimination rate constant in plasma (Vz/F) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 30 days
Standard noncompartmental methods will be used.
Renal clearance (CLR) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 7 days
Standard noncompartmental methods will be used.
Amount of drug excreted unchanged in urine (Ae) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 7 days
Standard noncompartmental methods will be used.
Fraction of eliminated dose in urine (Fe%) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Time frame: 7 days
Standard noncompartmental methods will be used.
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 8 Jan 2025.
- 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.
Cory D Sellwood, MBChB principal investigator
New Zealand Clinical Research
William K Schmidt, PhD study director
EicOsis Human Health Inc.
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 EC5026 oral tablet in people with Healthy Subjects, run by EicOsis Human Health Inc. at 1 site in New Zealand.
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 13 inclusion and 22 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 8 Jan 2025. 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 New Zealand. 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?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability] (time frame: 30 days). The study lists 13 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 8 Jan 2025.