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New data; the study was terminated based on new efficacy data
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This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with severe renal impairment (Group A) | Experimental |
| |
| Healthy subjects (Group B) | Experimental |
| |
| Subjects with moderate renal impairment (Group C) | Experimental |
| |
| Subjects with mild renal impairment (Group D) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 | Drug | Single dose, 10 mg film coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area under the Lu AF35700 plasma concentration-time curve from zero to infinity | Predose to day 57 postdose |
| Cmax | Maximum observed plasma concentration of Lu AF35700 | Predose to day 57 postdose |
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Inclusion Criteria:
-Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
-Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min
Exclusion Criteria:
-The subject has previously been dosed with Lu AF35700
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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 |
|---|---|
| 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 |
|---|---|
| C000726227 | Lu AF35700 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |