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NCT05572190
Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
Phase 1 trial testing ETR028, ETR029, [ETR028 + ETR029] or HCBT in Acute Pain in 78 participants. Status unknown.
20 March 2024
Quick facts
| Lead sponsor | Elysium Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 78 |
| Start date | 27 September 2022 |
| Primary completion | 20 March 2024 |
| Estimated completion | 31 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ETR028, ETR029, [ETR028 + ETR029] or HCBT — full drug profile →
Conditions studied
- Acute Pain — all drugs for Acute Pain →
Sponsor
Elysium Therapeutics, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05572190
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05572190 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Elysium Therapeutics, Inc.
- Last refreshed: 13 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05572190.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing