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drugset / Trial / NCT05572190

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

NCT05572190 ↗

Phase 1 Unknown 78 enrolled Elysium Therapeutics, Inc. Charles River Laboratories International Inc. · collabMedpace, Inc. · collabNational Institute on Drug Abuse (NIDA) · collabOhio Third Frontier · collab
RandomizedCrossoverSingle-blindBasic science

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

Timeline

Start
2022-09-27
Primary completion
2024-03-20
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ETR028 Unknown 30 mg Oral
Subject ETR028 Unknown 60 mg Oral
Subject ETR029 Unknown 30 mg Oral
Subject hydrocodone bitartrate Unknown 5 mg Oral
Subject hydrocodone bitartrate Unknown 10 mg Oral
Subject hydrocodone bitartrate Unknown 80 mg Oral

Indications

No indication recorded.