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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03745001




Registration number
NCT03745001
Ethics application status
Date submitted
3/10/2018
Date registered
19/11/2018
Date last updated
21/10/2019

Titles & IDs
Public title
To Evaluate the Safety and Tolerability, Pharmacokinetics, Food-effect and Pharmacodynamics of EHP-101 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
EHP-101-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EHP-101 Liquid single dose
Treatment: Drugs - EHP-101 Liquid multiple doses
Treatment: Drugs - Matching placebo

Experimental: Single dose study part - 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)

Experimental: Multiple dose study part - 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)


Treatment: Drugs: EHP-101 Liquid single dose
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).

Treatment: Drugs: EHP-101 Liquid multiple doses
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)

Treatment: Drugs: Matching placebo
Oral liquid administration daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From the time of the first dose and continued until 30 days after
Secondary outcome [1] 0 0
Time to reach VCE-004.8 maximum concentration after a single drug administration (Tmax).
Timepoint [1] 0 0
Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Secondary outcome [2] 0 0
Observed maximum VCE-004.8 serum concentration following single drug administration (Cmax).
Timepoint [2] 0 0
Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Starting 1 hour prior to dosing on Day 1 and until 192 hours after dosing on Day 9.
Secondary outcome [4] 0 0
Time to reach VCE-004.8 maximum concentration after a multiple drug administration (Tmax).
Timepoint [4] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 24 hours after the first dose administration on Day 7.
Secondary outcome [5] 0 0
Time to reach VCE-004.8 maximum concentration after a multiple drug administration (Tmax).
Timepoint [5] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12
Secondary outcome [6] 0 0
Observed maximum VCE-004.8 serum concentration following multiple drug administration (Cmax).
Timepoint [6] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 24 hours after the first dose administration on Day 8
Secondary outcome [7] 0 0
Observed maximum VCE-004.8 serum concentration following drug administration at steady state (Cmax,ss) after multiple drug administration
Timepoint [7] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the first dose administration on Day 12
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the first dose administration on Day 12
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
Secondary outcome [10] 0 0
The average steady state VCE-004.8 serum concentration during multiple dosing (Cav,ss) after multiple dose administration
Timepoint [10] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
Secondary outcome [11] 0 0
The effective VCE-004.8 half-life based on drug accumulation at steady state (T1/2,acc) after multiple dose administration
Timepoint [11] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.
Secondary outcome [12] 0 0
The accumulation VCE-004.8 ratio (Racc) after multiple drug administration
Timepoint [12] 0 0
Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12.

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any known, documented, or suspected history of:

1. schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a
first-degree relative.

2. alcohol or substance abuse within the last 2 years before screening or positive
test result(s) for alcohol and or drugs of abuse.

3. 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2019
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Emerald Health Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03745001
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Snyder, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries