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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004867-65 | EudraCT Number |
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The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ056 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume] (AUCinf) | Time Frame: Day 1 (period 1): 0.5, 2, 4, 8, 12, 24 hours post-dose; Day 7 (period 2): pre-dose; 0.5, 2, 4, 8 hours post dose | |
| The area under the plasma (or serum or blood) concentration-time curve from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUClast) | Time Frame: Day 1 (period 1): 0.5, 2, 4, 8, 12, 24 hours post-dose; Day 7 (period 2): pre-dose; 0.5, 2, 4, 8 hours post dose | |
| Maximum observed plasma concentration (Cmax) | Time Frame: Day 1 (period 1): 0.5, 2, 4, 8, 12, 24 hours post-dose; Day 7 (period 2): pre-dose; 0.5, 2, 4, 8 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination | Screening: once anytime between Day -30 and Day -1; once anytime between 24-72 hours after Day 7 | |
| Vital signs and body measurements | Screening: once anytime between Day -30 and Day -1; once anytime between 24-72 hours after Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sacramento | California | 95817 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CAFQ056B2154 can be found on the Novartis Clinical Trial Results Website | View source |
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| Electrocardiograms | Screening: once anytime between Day -30 and Day -1; once anytime between 24-72 hours after Day 7 |
| hematology | Screening: once anytime between Day -30 and Day -1; once anytime between 24-72 hours after Day 7 |
| blood chemistry | Screening: once anytime between Day -30 and Day -1; once anytime between 24-72 hours after Day 7 |
| neurological examination | Screening: once anytime between Day -30 and Day -1; once on Day 7 |
| Adverse events (AE) monitoring | During the study (total of approximately 32 days) and 3 days after study completion |
| Serious adverse events (SAE) monitoring | During the study (total of approximately 32 days) and 30 days after study completion |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Novartis Investigative Site | Nashville | Tennessee | 37232-7548 | United States |
| Novartis Investigative Site | Sant Cugat del Vallès | Catalonia | 08190 | Spain |
| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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