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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: nalmefene hydrochloride 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02679469

339-102-00003

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Nalmefene hydrochloride 10 mg

Experimental group

Description:

nalmefene 10 mg tablet

Treatment:

Drug: nalmefene hydrochloride 10 mg