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NCT05921929
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
Phase 1 trial testing Fluoroethylnormemantine (FENM) in PTSD. Withdrawn.
2 May 2024
Quick facts
| Lead sponsor | ReST Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Start date | 2 May 2024 |
| Primary completion | 2 May 2024 |
| Estimated completion | 2 May 2024 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Fluoroethylnormemantine (FENM) — full drug profile →
Conditions studied
- PTSD — all drugs for PTSD →
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Brain Diseases — all drugs for Brain Diseases →
- Neuro-Degenerative Disease — all drugs for Neuro-Degenerative Disease →
Sponsor
ReST Therapeutics — full company profile →
Who can join
Adults 18 to 45, male only, with PTSD or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: * What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)? * What is the PK profile of single ascending doses of the FENM in human? * What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05921929
- 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 NCT05921929 (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 ReST Therapeutics
- Last refreshed: 3 May 2024
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/NCT05921929.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing