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

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223097

Enrollment

Registered

2016-02-08

Start date

2016-02-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult male

Interventions

investigational material(s) Generic name etc : Nalmefene hydrochloride INN of investigational material : Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Admin

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - The subject is able to read and understand the informed consent form (ICF). - The subject has a body mass index (BMI) between 19 and 25 kg/m2 (inclusive) at the screening visit. - The subject has a resting pulse and heart rate (as read on the ECG) between 45 and 100 bpm (inclusive) at the screening visit.

Exclusion criteria

Exclusion criteria: - The subject has taken any prescription drugs, over-thecounter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1. - The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits). - The subject has taken any investigational products within 4 months prior to Day 1.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability, and pharmacokinetics	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026