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

NCT02679469 | Completed Phase 1 Results

• 1 other identifier: 339-102-00003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Nalmefene hydrochloride 10 mg

EXPERIMENTAL

nalmefene 10 mg tablet

Drug: nalmefene hydrochloride 10 mg

Interventions

nalmefene hydrochloride 10 mg DRUG

Nalmefene hydrochloride 10 mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Kyusyu

Region, Japan

Location

MeSH Terms

Conditions

Alcoholism

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Study Officials

• Jun-ichi Hashimoto, PhD

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 10, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-04

Locations

JP (1)