A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
- Conditions
- Prader-Willi Syndrome
- Interventions
- Registration Number
- NCT02893618
- Lead Sponsor
- Essentialis, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
- Ability to follow verbal and written instructions
- Informed consent form signed by the subject
- Completed screening within 7 days prior to dosing
- BMI between 18.5 and 35 kg/m2
- Generally healthy
- fasting glucose less than or equal to 100 mg/dL
- HbA1c less than or equal to 6%
- Pregnancy or breast feeding
- absence of contraception
- administration of investigational drug within 1 month prior to screening
- anticipated requirement for prohibited medication (systemic corticosteroids or anti-diabetic medications)
- allergic reaction to or significant intolerance of diazoxide, thiazides or sulfonamides
- known type 1 or type 2 diabetes mellitus
- congestive heart failure
- gastric bypass surgery
- history of drug or alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DCCR 150 mg fasted Diazoxide choline controlled-release tablet Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting DCCR 300 mg fasted Diazoxide choline controlled-release tablet Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting DCCR 300 mg fed Diazoxide choline controlled-release tablet Administered a single 300 mg dose of DCCR after a standardized meal DCCR 75 mg fasted Diazoxide choline controlled-release tablet Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting DCCR 450 mg fasted Diazoxide choline controlled-release tablet Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters: Cmax up to 24 hours Cmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose
Pharmacokinetic parameters: AUC0-24 up to 24 hours AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters: Tmax up to 24 hours Tmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Pharmacokinetic parameters: CL/F up to 24 hours CL/F derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours