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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005711-53 | EudraCT Number |
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To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nalmefene 18 mg | Experimental | 18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalmefene 18 mg | Drug | One single oral dose of 18 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf) | Up to 120 hours post-dose | |
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t) | Up to 120 hours post-dose | |
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax) | Up to 120 hours post-dose | |
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax) | Up to 120 hours post-dose | |
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½) | Up to 120 hours post-dose | |
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR) | Up to 120 hours post-dose | |
| For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F) | Up to 120 hours post-dose | |
| For nalmefene: apparent volume of distribution for nalmefene (Vz /F) | Up to 120 hours post-dose | |
| For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Number of adverse events | Up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DE801 | Munich | 81241 | Germany |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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| Up to 120 hours post-dose |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |