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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000748-28 | EudraCT Number |
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This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFQ056 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ056 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups | AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: : Number of subjects with adverse event in each group | Number and type of adverse events, number and type of findings in standard laboratory results, special laboratory results (Hypothaliamic-pituitary axis, porphyrin profile) electrocardiogram holters, or in vital signs | From dose administration (day 1) to 13+/- 2 days after the single dose administration |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Orlando | Florida | 32809 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CAFQ056A2123 can be found on the Novartis Clinical Trial Results website | View source |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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| Measure: Plasma protein binding results of AFQ056 in each groups. | 2 hours after single dose administration |
| Berlin |
| 10117 |
| Germany |
| Novartis Investigative Site | Balatonfüred | 8230 | Hungary |