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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004139-20 | 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 a single oral dose of Lu AF35700
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mild hepatic impairment (Group1) | Experimental |
| |
| Patients with moderate hepatic impairment (Group 2) | Experimental |
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| Healthy subjects (Group 3) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 | Drug | Single oral dose of 10 mg Lu AF35700 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf) | Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf) | Predose to day 57 postdose |
| Maximum observed plasma concentration (Cmax) of Lu AF35700 | Maximum observed plasma concentration (Cmax) of Lu AF35700 | Predose to day 57 postdose |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol 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 | Munich | Germany |
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| ID | Term |
|---|---|
| C000726227 | Lu AF35700 |
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