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

Alcohol Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679469
• Other study ID #: 339-102-00003
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2016
• Last updated: April 17, 2017
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• nalmefene hydrochloride 10 mg

Locations

Country	Name	City	State
Japan	Kyusyu	Region

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.	H. Lundbeck A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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