Back to resultsA Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
nalmefene hydrochloride 10 mg
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
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.
Sites / Locations
- Kyusyu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nalmefene hydrochloride 10 mg
Arm Description
nalmefene 10 mg tablet
Outcomes
Primary Outcome Measures
Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax)
Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)
Measure the Terminal-phase Elimination Half-life (T1/2)
Secondary Outcome Measures
Full Information
NCT ID
NCT02679469
First Posted
January 25, 2016
Last Updated
April 17, 2017
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT02679469
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalmefene hydrochloride 10 mg
Arm Type
Experimental
Arm Description
nalmefene 10 mg tablet
Intervention Type
Drug
Intervention Name(s)
nalmefene hydrochloride 10 mg
Primary Outcome Measure Information:
Title
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
Title
Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)
Time Frame
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-ichi Hashimoto, PhD
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Kyusyu
City
Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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
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