At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 84 enrolled
Drug / intervention
Nalmefene hydrochloride +1 moredrug
Likely dose
Nalmefene hydrochloride 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism
In Brief
A Phase 1 clinical trial evaluating Nalmefene hydrochloride and Naloxone hydrochloride for Pharmacodynamic. Completed, enrolled 84 participants across 1 site.
Detailed Summary
This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacodynamic
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedApr 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedApr 1, 2021
Enrollment StartMar 30, 2021
Primary CompletionMar 14, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.3 years ago
Interventions
Nalmefene hydrochloridedrug
3mg Nasal spray
Naloxone hydrochloridedrug
4mg Nasal Spray