At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 7 enrolled
Drug / intervention
nalmefene hydrochloride 10 mgdrug
Likely dose
nalmefene hydrochloride 10 mgfrom 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 Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
In Brief
A Phase 1 clinical trial evaluating nalmefene hydrochloride 10 mg for Alcohol Dependence. Completed, enrolled 7 participants across 1 site.
Detailed Summary
The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesJapan
CollaboratorsH. Lundbeck A/S
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedFeb 2016
Primary CompletionMar 2016
TodayJul 2026
First PostedFeb 10, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.4 years ago
Interventions
nalmefene hydrochloride 10 mgdrug