Alcohol Dependence
Conditions
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.
Interventions
DRUGnalmefene hydrochloride 10 mg
Sponsors
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nalmefene Hydrochloride 10 mg nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Nalmefene Hydrochloride 10 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 21.6 years STANDARD_DEVIATION 0.8 |
| Region of Enrollment Japan | 7 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nalmefene Hydrochloride 10 mg | Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt) | 61.8 ng･h/mL | Standard Deviation 18 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nalmefene Hydrochloride 10 mg | Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax) | 8.88 ng/mL | Standard Deviation 3.34 |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nalmefene Hydrochloride 10 mg | Measure the Terminal-phase Elimination Half-life (T1/2) | 12.1 hours |