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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004449-18 | EudraCT Number |
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The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mild hepatic impairment (Group1) | Experimental | 8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054 |
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| Patients with moderate hepatic impairment (Group 2) | Experimental | 8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054. |
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| Healthy subjects (Group 3) | Experimental | 8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AE58054 encapsulated film-coated tablets | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf) | 0 to 96 hours | |
| Maximum observed plasma concentration (Cmax) of Lu AE58054 | 0 to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG) | Screening to day 11 |
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Inclusion Criteria:
Other pre-defined 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 |
|---|---|---|---|---|---|---|
| APEX GmbH | Munich | Germany |
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