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Opioid Analgesic

ETR028 + ETR029 for Acute Pain

Phase 1
Recruiting
Led By Leela Vrishabhendra, MD
Research Sponsored by Elysium Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be male or female, 18 to 55 years of age, at the Screening Visit
Subjects must be in general good health based upon medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time zero (just prior to dose) to 48 hours post dose timepoints: pre-dose and at 0.5,1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose.
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of two new drugs relative to a comparator drug, hydrocodone bitartrate hemipentahydrate. The trial will test subjects under both fasted and fed conditions, with naltrexone blockade.

Who is the study for?
Healthy adults aged 18-55, with a BMI of 18-32 kg/m2 and good overall health are eligible for this trial. They must have previously tolerated opioids, have normal kidney function and blood tests, agree to contraception rules if applicable, and follow study procedures including eating a high-fat meal.Check my eligibility
What is being tested?
The trial is testing the safety and how the body processes two new hydrocodone drugs (ETR028 & ETR029) compared to an existing drug (HCBT). Participants will take single doses under different conditions (with or without food) while also taking naltrexone to block opioid effects.See study design
What are the potential side effects?
Possible side effects may include typical opioid-related issues such as nausea, vomiting, constipation, drowsiness or dizziness. Since it's a Phase 1 trial focused on healthy individuals, detailed side effect profiles will be determined during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I am in good health overall, based on recent medical exams and tests.
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My kidney function, measured by eGFR, is 60 mL/min/1.73 m2 or higher.
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I am following the required contraception guidelines.
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I have taken prescription opioids before without severe side effects.
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I am following the required birth control guidelines due to my potential to conceive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time zero (just prior to dose) to 48 hours post dose timepoints: pre-dose and at 0.5,1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time zero (just prior to dose) to 48 hours post dose timepoints: pre-dose and at 0.5,1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pyruvate Kinase
Subjects reporting at least one Adverse Event (AE)
Subjects reporting at least one Serious Adverse Event (SAE)

Trial Design

17Treatment groups
Experimental Treatment
Active Control
Group I: B6. [ETR028 + ETR029] blend "1", "2", "3", or "4"Experimental Treatment1 Intervention
8-fold higher dose of [ETR028 + ETR029] blend "1", "2", "3", or "4" single oral dose (fed)
Group II: B5. [ETR028 + ETR029] blend "1", "2", "3", or "4"Experimental Treatment1 Intervention
8-fold higher dose of [ETR028 + ETR029] blend "1", "2", "3", or "4" single oral dose (fasted)
Group III: B4. [ETR028 + ETR029] blend "1", "2", "3", or "4"Experimental Treatment1 Intervention
4-fold higher dose of [ETR028 + ETR029] blend "1", "2", "3", or "4" single oral dose (fasted)
Group IV: B3. [ETR028 + ETR029] blend "1", "2", "3", or "4" (fed)Experimental Treatment1 Intervention
[ETR028 - dose TBD + ETR029 - <=30mg] single oral dose (fed)
Group V: B3. [ETR028 + ETR029] blend "1", "2", "3", or "4" (fasted)Experimental Treatment1 Intervention
2-fold higher dose of [ETR028 + ETR029] blend "1", "2", "3", or "4" single oral dose (fasted)
Group VI: B2. [ETR028 + ETR029] blend "4"Experimental Treatment1 Intervention
[ETR028 - dose TBD + ETR029 - <=30mg] single oral dose (fasted)
Group VII: B2. [ETR028 + ETR029] blend "3"Experimental Treatment1 Intervention
[ETR028 - dose TBD + ETR029 - <=30mg] single oral dose (fasted)
Group VIII: B1. [ETR028 + ETR029] blend "2"Experimental Treatment1 Intervention
[ETR028 - dose TBD + ETR029 - <=30mg] single oral dose (fasted)
Group IX: B1. [ETR028 + ETR029] blend "1"Experimental Treatment1 Intervention
[ETR028 - dose To Be Determined (TBD) + ETR029 - <=30mg] single oral dose (fasted)
Group X: A2. <=60mg ETR028Experimental Treatment1 Intervention
<=60 mg ETR028 single oral dose (fasted)
Group XI: A1.2. 30 mg ETR029Experimental Treatment1 Intervention
30 mg ETR029 single oral dose (fasted)
Group XII: A1.2. 30 mg ETR028Experimental Treatment1 Intervention
30 mg ETR028 single oral dose (fasted)
Group XIII: A1.1. 30 mg ETR029 SentinelExperimental Treatment1 Intervention
30 mg ETR029 single oral dose (fasted)
Group XIV: A1.1. 30 mg ETR028 SentinelExperimental Treatment1 Intervention
30 mg ETR028 single oral dose (fasted)
Group XV: A2. <= 80mg HCBTActive Control1 Intervention
<= 80mg HCBT single oral dose (fasted)
Group XVI: A1.1. 5 mg HCBTActive Control1 Intervention
5 mg hydrocodone bitartrate (HCBT) single oral dose (fasted)
Group XVII: A1.1. 10 mg HCBTActive Control1 Intervention
10 mg HCBT single oral dose (fasted)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Charles River Laboratories International Inc.UNKNOWN
Ohio Third FrontierOTHER
5 Previous Clinical Trials
613 Total Patients Enrolled
Elysium Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA confirmed permission for A2. <=60mg ETR028?

"Due to the lack of data on A2. <=60mg ETR028's efficacy and safety, our team at Power gave this drug a rating of 1 out of 3."

Answered by AI

Could I be a potential subject in this research project?

"This medical trial is seeking 78 individuals to join, all of whom should suffer from acute pain and be between 18-55 years old."

Answered by AI

Does this research encompass individuals aged 35 and older?

"This trial's prerequisite for entry is that the participant should be between 18 to 55 years of age. However, there are 20 more trials specifically designed for minors and 116 options available for seniors above 65."

Answered by AI

Are there any opportunities for participants in this trial at present?

"Data hosted on clinicaltrials.gov attests that this medical trial, which commenced on September 27th 2022, is actively enrolling participants. The study's information was most recently modified in October 7th of the same year."

Answered by AI

What is the aggregate size of the population involved in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this study is currently recruiting participants who meet the criteria. It was initially posted on September 27th 2022 and has been recently updated as of October 7th 2022. A total of 78 subjects are needed across 1 site for this trial."

Answered by AI
~31 spots leftby Mar 2025