Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
Status unconfirmed · Phase 1
Conditions studied: Acute Pain
In brief
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
Key facts
- Study ID
- NCT05572190
- Run by
- Elysium Therapeutics, Inc.
- People needed
- 78
- Starts
- 2022-09-27
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2023-09-13
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Medpace — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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