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

Phase 1

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: nalmefene hydrochloride 10 mg

• Registration Number: NCT02679469
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-03-06
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Results First Posted: 2017-04-18
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

• The subject is a Japanese male.
• The subject is able to read and understand the informed consent form (ICF).
• The subject has a body mass index (BMI) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening visit.
• The subject has a resting pulse and heart rate (as read on the ECG) ≥ 45 bpm and ≤ 100 bpm at the screening visit.

Exclusion Criteria

• The subject has taken any prescription drugs, over-the counter 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nalmefene hydrochloride 10 mg	nalmefene hydrochloride 10 mg	nalmefene 10 mg tablet

Primary Outcome Measures

Name	Time	Method
Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax)	pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)	pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Measure the Terminal-phase Elimination Half-life (T1/2)	pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

Trial Locations

Locations (1)

Kyusyu; 🇯🇵 Region, Japan