Overview

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

Status:
Recruiting
Trial end date:
2023-03-31
Target enrollment:
Participant gender:
Summary
The goal of this Phase 1 clinical study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of O2P 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
Phase:
Phase 1
Details
Lead Sponsor:
Elysium Therapeutics, Inc.
Collaborators:
Charles River Labs
Medpace, Inc.
National Institute on Drug Abuse (NIDA)
Ohio Third Frontier
Treatments:
Hydrocodone