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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nalmefene hydrochloride 10 mg | Experimental | nalmefene 10 mg tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalmefene hydrochloride 10 mg | Drug |
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun-ichi Hashimoto, PhD | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu | Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nalmefene Hydrochloride 10 mg | nalmefene 10 mg tablet nalmefene hydrochloride 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nalmefene Hydrochloride 10 mg | nalmefene 10 mg tablet nalmefene hydrochloride 10 mg |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax) | Posted | Mean | Standard Deviation | ng/mL | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose |
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| Primary | Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt) | Posted | Mean | Standard Deviation | ng・h/mL | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose |
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| Primary | Measure the Terminal-phase Elimination Half-life (T1/2) | Posted | Median | Full Range | hours | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose |
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From consent acquisition until 5 days after administration of Investigational Medicinal Product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nalmefene Hydrochloride 10 mg | nalmefene 10 mg tablet nalmefene hydrochloride 10 mg | 0 | 7 | 1 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA Ver.19.0 MedD | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver.19.0 MedD | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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