Clinical Trials Logo
  1. Home
  2. Acute Pain
  3. NCT05572190

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
See also
  Status Clinical Trial Phase
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT03825549 - A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing N/A
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Terminated NCT04716413 - Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Phase 4
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Not yet recruiting NCT06317844 - Examination of Psychological and Physiological Pathways Linking Gratitude and Pain N/A
Withdrawn NCT02957097 - Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures Phase 4
Terminated NCT02599870 - Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures N/A
Completed NCT02565342 - Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery Phase 4
Completed NCT02380989 - Integrative Ayurveda Healing Relieves Minor Sports Injury Pain Phase 2
Completed NCT02984098 - 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose Phase 4
Completed NCT02489630 - Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department Phase 4
Completed NCT03107338 - Preventive Treatment of Pain After Dental Implant Surgery Phase 4
Completed NCT02817477 - Intranasal Ketamine for Acute Traumatic Pain Phase 4
Completed NCT00609466 - A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy Phase 3