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 logo

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)

7 participants in 1 patient group

Nalmefene hydrochloride 10 mg
Experimental group
Description:
nalmefene 10 mg tablet
Treatment:
Drug: nalmefene hydrochloride 10 mg

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems