HealthyPhase 1NCT03745001
To Evaluate the Safety and Tolerability, Pharmacokinetics, Food-effect and Pharmacodynamics of EHP-101 in Healthy Volunteers
A Phase 1 study testing EHP-101 Liquid single dose and EHP-101 Liquid multiple doses in people with Healthy, run by Emerald Health Pharmaceuticals at 1 site in Australia.
Trial summary
The study will assess the safety and tolerability, pharmacodynamic, pharmacokinetic profiles, and food effect of single ascending doses and multiple ascending doses (7 consecutive days) after daily oral administration in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EHP-101 Liquid single dose and EHP-101 Liquid multiple doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Sep 2018to 13 Sep 2019
- 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
- Healthy male or female subjects ≥ 18 to ≤ 65 years of age.
- Body mass index (BMI) range 18 to 34 kg/m².
- Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG), echocardiography, ophthalmologic examinations and tests, and laboratory evaluations at screening and admission, as judged by the Investigator.
- Cardiac Troponin I level below the upper limit of normal, as defined by the manufacturer.
- Ability to understand and the willingness to provide informed consent for participation in the study.
- Ability and willingness, as judged by the Investigator, to comply with all study requirements.
Who cannot join
- Any known, documented, or suspected history of:
- schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative.
- alcohol or substance abuse within the last 2 years before screening or positive test result(s) for alcohol and or drugs of abuse.
- Regular alcohol consumption >21 units per week
- Use of nicotine or nicotine-containing products during participation in the study.
- Caffeine consumption is limited to no more than 2 units per day.
Show all 19Show fewer
- Any known, documented, or suspected hypersensitivity to cannabinoids or any of the excipients of EHP-101 Liquid.
- Use of cannabis or cannabinoid-based medications.
- Abnormal screening 12-lead ECG interpreted by the Investigator to be clinically significant.
- Presence of ophthalmologic abnormalities at baseline, specifically known closed angles, previous laser iridotomy, or severe hypermetropic diagnosis.
- Male subjects who are not surgically sterilized and who do not agree to use condoms in combination with partner use of a highly effective method of contraception. Female subjects of childbearing potential who are not using a highly effective method of contraception, as judged by the Investigator, and who do not consent: i) to use a combined barrier method of contraception and ii) to remain on a highly effective method of contraception while receiving study intervention during the study and for at least 90 days after the end of study treatment.
- Female subjects who are pregnant, lactating, or planning pregnancy during the course of the study and for 12 weeks thereafter.
- Male subjects unwilling to abstain from sperm donation during the study and for 12 weeks thereafter.
- Any evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV types 1 and 2) infection.
- Subjects who have received an IP within the 12 weeks before the screening visit.
- Blood donation or loss (eg, ≥ 400 mL) within 3 months before enrollment and unwilling to abstain from blood donation during the study.
- Significant disease or disorder, which, in the opinion of the Investigator or other staff who is directly involved in the study, may either put the subject at risk because of participation in the study or interfere with the subject's ability to participate in the study.
- Intake of any metabolic enzyme-affecting drugs from 30 days prior to Day -1 (ie, Check-in).
- Vaccination within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Food Effect of Single Ascending Doses and Multiple Ascending Doses of EHP-101 in Healthy Subjects
The study will assess the safety and tolerability, pharmacodynamic, pharmacokinetic profiles, and food effect of single ascending doses and multiple ascending doses (7 consecutive days) after daily oral administration in healthy male and female subjects.
Read the detailed description
This Phase 1, single center, randomized, double-blind, placebo-controlled study will be conducted in 2 parts: the single ascending dosing (SAD) will constitute Part 1 and the multiple ascending dosing (MAD) will constitute Part 2. In Part 1 (ie, SAD) of the study, up to 64 eligible subjects will be randomized with an allocation ratio of 3:1 to receive EHP-101 Liquid or matching placebo within one of up to 8 sequential cohorts; Sentinel subjects (1 receiving EHP-101 Liquid and 1 receiving placebo) will be dosed prior to dosing the remaining 6 subjects to allow for observation of adverse reactions before exposing the Investigational Product (IP) to a greater number of subjects, in the SAD cohorts. In Part 2 of the study, up to 40 eligible subjects will be randomized with an allocation ratio of 4:1 to receive EHP 101 Liquid or matching placebo within one of up to 4 cohorts. Dose-escalations, initiation of a single-dose food effect cross-over investigation and the start of the MAD part of the study will be coordinated by a Safety Review Committee (SRC) following review of available safety data.
- Conditions
- Healthy
- Being tested
- EHP-101 Liquid single dose, EHP-101 Liquid multiple doses, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHP-101 Liquid single doseDrug
One single oral administration with EHP-101 liquid formulation. The doses will be ascending per cohort from 0.91 mg to 200 mg. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day).
EHP-101 Liquid multiple dosesDrug
One single daily administration with EHP-101 liquid formulation during 7 consecutive days. The doses will be ascending per cohort. Each ascending level will not exceed the tested dose levels in the single dose part of the study. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day)
Matching placeboDrug
Oral liquid administration daily
| Study group | Role | What they receive |
|---|---|---|
| Single dose study part | Experimental | there will be 7 cohorts of healthy volunteers dosed with single doses of EHP-101 (7 planned dose levels) or with placebo and 1 potential additional cohort (also dosed with single dose of EHP-101 or placebo) Receives: Drug: EHP-101 Liquid single dose; Drug: Matching placebo |
| Multiple dose study part | Experimental | there will be 3 cohorts of healthy volunteers dosed with multiple doses of EHP-101 (3 planned dose levels) or placebo and 1 potential additional cohort (also dosed with multiple doses of EHP-101 or placebo) Receives: Drug: EHP-101 Liquid multiple doses; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) following single and multiple ascending oral doses for 30 days after dosing.
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Measured: From the time of the first dose and continued until 30 days after
Secondary outcomes (12)
Time to reach VCE-004.8 maximum concentration after a single drug administration (Tmax).
Serum samples will be collected on Day 1: 1 hour predose; 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours post dose, on Day 2: 24 hours post dose, on Day 3: 48 hours post dose, on Day 4: 72 hours post dose, on Day 5: 96 hours postdose, on Day 6: 120 hours postdose, on Day 7: 144 hours post dose, on Day 8, 168 hours, on Day 9: 192 hours post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above. * samples to be collected on Day 1 only for the modified dose regimen.
In one cohort the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on VCE-004.8 Tmax.
Measured: Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Observed maximum VCE-004.8 serum concentration following single drug administration (Cmax).
Serum samples will be collected on Day 1: 1 hour predose; 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours post dose, on Day 2: 24 hours post dose, on Day 3: 48 hours post dose, on Day 4: 72 hours post dose, on Day 5: 96 hours postdose, on Day 6: 120 hours postdose, on Day 7: 144 hours post dose, on Day 8, 168 hours, on Day 9: 192 hours post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above. * samples to be collected on Day 1 only for the modified dose regimen.
In one cohort the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on VCE-004.8 Cmax.
Measured: Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Area under the serum VCE-004.8 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) following single drug administration.
Serum samples will be collected on Day 1: 1 hour predose; 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*, 15 hours*; 16 hours post dose, on Day 2: 24 hours post dose, on Day 3: 48 hours post dose, on Day 4: 72 hours post dose, on Day 5: 96 hours postdose, on Day 6: 120 hours postdose, on Day 7: 144 hours post dose, on Day 8, 168 hours, on Day 9: 192 hours post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 only for the modified dose regimen.
In one cohort the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on VCE-004.8 AUClast
Measured: Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Time to reach VCE-004.8 maximum concentration after a multiple drug administration (Tmax).
Serum samples will be collected on Day 1 and Day7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*, 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose.
This outcome measure shows the mean of all subject values resulting from each time point specified above.*samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 24 hours after the first dose administration on Day 7.
Time to reach VCE-004.8 maximum concentration after a multiple drug administration (Tmax).
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose.
This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12
Observed maximum VCE-004.8 serum concentration following multiple drug administration (Cmax).
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 24 hours after the first dose administration on Day 8
Observed maximum VCE-004.8 serum concentration following drug administration at steady state (Cmax,ss) after multiple drug administration
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the first dose administration on Day 12
Area under the serum VCE-004.8 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration during multiple drug administration
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the first dose administration on Day 12
The area under the serum VCE-004.8 concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) during multiple drug administration
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
The average steady state VCE-004.8 serum concentration during multiple dosing (Cav,ss) after multiple dose administration
Serum samples will be collected on Day 1: 1 hour predose; 0,25 hour; 0,5 hour; 1 hour; 1,5 hours; 2 hours; 3 hours; 4 hours; 6 hours; 8 hours; 12 hours; 14 hours*; 15 hours*; 16 hours post dose, on Day 2: 24 hours post dose, on Day 3: 1 hour prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1 hour prior dosing, on Day 15 (last time the drug is administered): 1 hour predose; 0,25 hour; 0,5 hour; 1 hour; 1,5 hours; 2 hours; 3 hours; 4 hours; 6 hours; 8 hours; 12 hours; 16 hours post dose, on Day 16: 24 hours post dose and Day 17: 48 hours post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
The effective VCE-004.8 half-life based on drug accumulation at steady state (T1/2,acc) after multiple dose administration
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
The accumulation VCE-004.8 ratio (Racc) after multiple drug administration
Serum samples will be collected on Day 1 and Day 7: 1 hour predose; Day 1 and 7: 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours*; 15 hours*; 16 hours and on Day 8: 24 hours post dose, on Day 9: 48 hours post dose, on Day 10: 72 hours post dose, on Day 11: 96 hours postdose, and on Day 12: 120 hours postdose. This outcome measure shows the mean of all subject values resulting from each time point specified above. *samples to be collected on Day 1 and Day 7 only for the modified dose regimen.
Measured: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start14 Sep 2018
- Primary completion11 Aug 2019
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emerald Health Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Snyder, MD, Study chair, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745001
- Sponsor's protocol ID
- EHP-101-01
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Food Effect of Single Ascending Doses and Multiple Ascending Doses of EHP-101 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03745001
- Acronym / sponsor ID
- EHP-101-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Emerald Health PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 11 Aug 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 19 Nov 2018 (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.
The study will assess the safety and tolerability, pharmacodynamic, pharmacokinetic profiles, and food effect of single ascending doses and multiple ascending doses (7 consecutive days) after daily oral administration in healthy male and female subjects.
Detailed description
This Phase 1, single center, randomized, double-blind, placebo-controlled study will be conducted in 2 parts: the single ascending dosing (SAD) will constitute Part 1 and the multiple ascending dosing (MAD) will constitute Part 2. In Part 1 (ie, SAD) of the study, up to 64 eligible subjects will be randomized with an allocation ratio of 3:1 to receive EHP-101 Liquid or matching placebo within one of up to 8 sequential cohorts; Sentinel subjects (1 receiving EHP-101 Liquid and 1 receiving placebo) will be dosed prior to dosing the remaining 6 subjects to allow for observation of adverse reactions before exposing the Investigational Product (IP) to a greater number of subjects, in the SAD cohorts. In Part 2 of the study, up to 40 eligible subjects will be randomized with an allocation ratio of 4:1 to receive EHP 101 Liquid or matching placebo within one of up to 4 cohorts. Dose-escalations, initiation of a single-dose food effect cross-over investigation and the start of the MAD part of the study will be coordinated by a Safety Review Committee (SRC) following review of available safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study
| Arm | Type | Receives |
|---|---|---|
| Single dose study part | Experimental | Drug: EHP-101 Liquid single dose, Drug: Matching placebothere will be 7 cohorts of healthy volunteers dosed with single doses of EHP-101 (7 planned dose levels) or with placebo and 1 potential additional cohort (also dosed with single dose of EHP-101 or placebo) |
| Multiple dose study part | Experimental | Drug: EHP-101 Liquid multiple doses, Drug: Matching placebothere will be 3 cohorts of healthy volunteers dosed with multiple doses of EHP-101 (3 planned dose levels) or placebo and 1 potential additional cohort (also dosed with multiple doses of EHP-101 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)
- Healthy male or female subjects ≥ 18 to ≤ 65 years of age.
- Body mass index (BMI) range 18 to 34 kg/m².
- Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG), echocardiography, ophthalmologic examinations and tests, and laboratory evaluations at screening and admission, as judged by the Investigator.
- Cardiac Troponin I level below the upper limit of normal, as defined by the manufacturer.
- Ability to understand and the willingness to provide informed consent for participation in the study.
Key exclusion criteria (19 listed)
- Any known, documented, or suspected history of:
- Use of nicotine or nicotine-containing products during participation in the study.
- Caffeine consumption is limited to no more than 2 units per day.
- Any known, documented, or suspected hypersensitivity to cannabinoids or any of the excipients of EHP-101 Liquid.
- Use of cannabis or cannabinoid-based medications.
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 |
|---|---|---|
| EHP-101 Liquid single doseOne single oral administration with EHP-101 liquid formulation. The doses will be ascending per cohort from 0.91 mg to 200 mg. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day). | Drug | Single dose study part |
| EHP-101 Liquid multiple dosesOne single daily administration with EHP-101 liquid formulation during 7 consecutive days. The doses will be ascending per cohort. Each ascending level will not exceed the tested dose levels in the single dose part of the study. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day) | Drug | Multiple dose study part |
| Matching placeboOral liquid administration daily | Drug | Multiple dose study part, Single dose study part |
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) following single and multiple ascending oral doses for 30 days after dosing.
Time frame: From the time of the first dose and continued until 30 days after
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
12 secondary outcomes
Time to reach VCE-004.8 maximum concentration after a single drug administration (Tmax).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Observed maximum VCE-004.8 serum concentration following single drug administration (Cmax).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Area under the serum VCE-004.8 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) following single drug administration.
Time frame: Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Time to reach VCE-004.8 maximum concentration after a multiple drug administration (Tmax).
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 24 hours after the first dose administration on Day 7.
Time to reach VCE-004.8 maximum concentration after a multiple drug administration (Tmax).
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12
Observed maximum VCE-004.8 serum concentration following multiple drug administration (Cmax).
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 24 hours after the first dose administration on Day 8
Observed maximum VCE-004.8 serum concentration following drug administration at steady state (Cmax,ss) after multiple drug administration
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the first dose administration on Day 12
Area under the serum VCE-004.8 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration during multiple drug administration
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the first dose administration on Day 12
The area under the serum VCE-004.8 concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) during multiple drug administration
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
The average steady state VCE-004.8 serum concentration during multiple dosing (Cav,ss) after multiple dose administration
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
The effective VCE-004.8 half-life based on drug accumulation at steady state (T1/2,acc) after multiple dose administration
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
The accumulation VCE-004.8 ratio (Racc) after multiple drug administration
Time frame: Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
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 21 Oct 2019.
- 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.
Ben Snyder, MD study chair
Nucleus Network
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 EHP-101 Liquid single dose and EHP-101 Liquid multiple doses in people with Healthy, run by Emerald Health Pharmaceuticals at 1 site in Australia.
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 19 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 21 Oct 2019. 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 Australia. 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?
Number of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) following single and multiple ascending oral doses for 30 days after dosing. (time frame: From the time of the first dose and continued until 30 days after). 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 21 Oct 2019.