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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005647-25 | EudraCT Number |
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The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idalopirdine (Lu AE58054) 60 mg (Group A) | Experimental | 8 patients with severe renal impairment and not on dialysis |
|
| Idalopirdine (Lu AE58054) 60 mg (Group B) | Experimental | 8 healthy subjects |
|
| Idalopirdine (Lu AE58054) 60 mg (Group C) | Experimental | Group C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B 8 patients with moderate renal impairment |
|
| Idalopirdine (Lu AE58054) 60 mg (Group D) | Experimental | Group D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B 8 patients with mild renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idalopirdine (Lu AE58054) 60 mg | Drug | encapsulated film-coated tablets for oral use once daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24) | Day 10 | |
| Maximum observed concentration (Cmax) of Lu AE58054 | 0-12 hours day 10 |
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Inclusion Criteria:
Exclusion Criteria:
•The subject has taken disallowed medication <1 week prior to the first dose of IMP or <5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)
Other protocol defined inclusion and exclusion criteria do apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DE801 | München | Germany |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C568612 | (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |