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Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food.
Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food, with a 10 Day washout period between treatments. There will be 8 treatment sequences with 4 subjects randomized to each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCCR 75 mg fasted | Experimental | Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting |
|
| DCCR 150 mg fasted | Experimental | Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting |
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| DCCR 300 mg fasted | Experimental | Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting |
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| DCCR 450 mg fasted | Experimental | Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting |
|
| DCCR 300 mg fed | Experimental | Administered a single 300 mg dose of DCCR after a standardized meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazoxide choline controlled-release tablet | Drug | QD tablet formulation of choline salt of diazoxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Cmax | Cmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose | up to 24 hours |
| Pharmacokinetic parameters: AUC0-24 | AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: CL/F | CL/F derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours | up to 24 hours |
| Pharmacokinetic parameters: Tmax | Tmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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|
| up to 24 hours |
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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