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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679469
Recruitment Status : Completed
First Posted : February 10, 2016
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: nalmefene hydrochloride 10 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nalmefene hydrochloride 10 mg
nalmefene 10 mg tablet
Drug: nalmefene hydrochloride 10 mg



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679469


Locations
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Japan
Kyusyu
Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Investigators
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Study Director: Jun-ichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02679469    
Other Study ID Numbers: 339-102-00003
First Posted: February 10, 2016    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents