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

NCT03745001 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-10-21

No results posted yet for this study

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

Interventions

DRUG

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).

DRUG

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)

DRUG

Matching placebo

Oral liquid administration daily

Sponsors & Collaborators

  • Emerald Health Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Ben Snyder, MD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2019-08-11
Completion
2019-09-13

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745001 on ClinicalTrials.gov