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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: 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.
Trial Safety
Safety Progress
Side Effects for
Trial Design
17 Treatment Groups
A2. <= 80mg HCBT
1 of 17
A1.1. 10 mg HCBT
1 of 17
A1.1. 5 mg HCBT
1 of 17
B3. [ETR028 + ETR029] blend "1", "2", "3", or "4" (fasted)
1 of 17
B6. [ETR028 + ETR029] blend "1", "2", "3", or "4"
1 of 17
B2. [ETR028 + ETR029] blend "4"
1 of 17
A1.1. 30 mg ETR028 Sentinel
1 of 17
B4. [ETR028 + ETR029] blend "1", "2", "3", or "4"
1 of 17
A1.2. 30 mg ETR028
1 of 17
A1.1. 30 mg ETR029 Sentinel
1 of 17
B1. [ETR028 + ETR029] blend "2"
1 of 17
B2. [ETR028 + ETR029] blend "3"
1 of 17
B5. [ETR028 + ETR029] blend "1", "2", "3", or "4"
1 of 17
A1.2. 30 mg ETR029
1 of 17
A2. <=60mg ETR028
1 of 17
B1. [ETR028 + ETR029] blend "1"
1 of 17
B3. [ETR028 + ETR029] blend "1", "2", "3", or "4" (fed)
1 of 17
Active Control
Experimental Treatment
78 Total Participants · 17 Treatment Groups
Primary Treatment: B3. [ETR028 + ETR029] blend "1", "2", "3", or "4" (fasted) · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 55 · All Participants · 15 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor