Last reviewed · How we verify

NCT05572190

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

Status unknown Phase 1 Last updated 13 September 2023
What this trial tests

Phase 1 trial testing ETR028, ETR029, [ETR028 + ETR029] or HCBT in Acute Pain in 78 participants. Status unknown.

Timeline
27 September 2022
Primary endpoint
20 March 2024
31 March 2024

Quick facts

Lead sponsorElysium Therapeutics, Inc.
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposebasic science
Enrollment78
Start date27 September 2022
Primary completion20 March 2024
Estimated completion31 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Elysium Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Acute Pain

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05572190.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing