NCT03745001

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Emerald Health Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-14
• Primary completion: 2019-08-11
• Completion: 2019-09-13
• First posted: 2018-11-19
• Last updated: 2019-10-21

Locations

1 site across 1 country: Australia