Overview

This trial has been completed.

Condition alcohol dependence
Treatment nalmefene hydrochloride 10 mg
Phase phase 1
Sponsor Otsuka Pharmaceutical Co., Ltd.
Collaborator H. Lundbeck A/S
Start date February 2016
End date March 2016
Trial size 7 participants
Trial identifier NCT02679469, 339-102-00003

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg

Primary Outcomes

Measure
Plasma concentrations of nalmefene
time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Measure the Maximum (peak) plasma concentration of the drug (Cmax)
time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Measure the Time to maximum (peak) plasma concentration (AUC)
time frame: 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)
time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Number of adverse events
time frame: Date of informed consent to days 5 post-dose

Eligibility Criteria

Male participants from 20 years up to 45 years old.

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 information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..