To Evaluate the Safety and Tolerability, Pharmacokinetics, Food-effect and Pharmacodynamics of EHP-101 in Healthy Volunteers

NCT03745001 | Completed Phase 1 DMC

• 1 other identifier: EHP-101-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  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).

  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.

  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).

  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).

  Starting 1 hour prior the first dose administration (Day 1) until 120 hours after the last dose administration on Day 12

Study Arms (2)

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)

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)

Drug: EHP-101 Liquid multiple doses; Drug: Matching placebo

Interventions

EHP-101 Liquid single dose DRUG

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).

Single dose study part

EHP-101 Liquid multiple doses DRUG

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)

Multiple dose study part

Matching placebo DRUG

Oral liquid administration daily

Multiple dose study part; Single dose study part

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Emerald Health Pharmaceuticals: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Ben Snyder, MD

  Nucleus Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: EHP-101 Liquid or matching placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 19, 2018
• Study Start: September 14, 2018
• Primary Completion: August 11, 2019
• Study Completion: September 13, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)