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

NCT05572190 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-09-13

No results posted yet for this study

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

Conditions

  • Acute Pain

Interventions

DRUG

ETR028, ETR029, [ETR028 + ETR029] or HCBT

Hydrocodone prodrugs

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Charles River Laboratories International Inc.

    collaborator UNKNOWN

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Ohio Third Frontier

    collaborator OTHER

  • Elysium Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Leela Vrishabhendra, MD · Medpace, Inc.

  • Lynn Webster, MD · Elysium Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2024-03-20
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05572190 on ClinicalTrials.gov