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Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects

Acute Pain Clinical Trial

Official title:
A Phase 1, Randomized, Open-Label, 2-Part Study to Evaluate the Safety and Pharmacokinetics of ETR028 Acetate and ETR029 Acetate in Healthy Adult Subjects

Clinical Trial Summary

The goal of this Phase 1 clinical study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of O2P (Oral Overdose Protected) hydrocodone prodrugs (ETR028 and ETR029) relative to hydrocodone bitartrate hemipentahydrate (HCBT) comparator following single oral doses in healthy adult subjects under fasted and fed conditions with naltrexone blockade

Clinical Trial Description

This is a Phase 1, randomized, single-site, open-label, single dose, 2-part study to evaluate the safety and PK of immediate release O2P hydrocodone (comprised of prodrug ETR028 or a blend of ETR028 and ETR029 prodrugs) against an HCBT comparator in healthy adult subjects when administered under fasted and fed conditions with naltrexone blockade. Up to approximately 78 healthy adult subjects are planned to be enrolled with each subject participating in 1 treatment period except for subjects in O2P hydrocodone treatment periods crossed over to receive O2P hydrocodone under fed conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05572190
Study type Interventional
Source Elysium Therapeutics, Inc.
Contact Brady Hamel, MS
Phone 866.872.2349
Email B.Hamel@Medpace.com
Status Recruiting
Phase Phase 1
Start date September 27, 2022
Completion date March 31, 2024
View Details
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