A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)

Study Overview
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Brief Summary
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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.

Detailed Description
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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, with a 10 Day washout period between treatments. There will be 8 treatment sequences with 4 subjects randomized to each.

Official Title
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A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)

Conditions
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Prader-Willi Syndrome

Intervention / Treatment
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* Drug: Diazoxide choline controlled-release tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCCR 75 mg fasted<br>Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting | Drug: Diazoxide choline controlled-release tablet<br>* QD tablet formulation of choline salt of diazoxide<br>* Other names: DCCR;|
| Experimental: DCCR 150 mg fasted<br>Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting | Drug: Diazoxide choline controlled-release tablet<br>* QD tablet formulation of choline salt of diazoxide<br>* Other names: DCCR;|
| Experimental: DCCR 300 mg fasted<br>Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting | Drug: Diazoxide choline controlled-release tablet<br>* QD tablet formulation of choline salt of diazoxide<br>* Other names: DCCR;|
| Experimental: DCCR 450 mg fasted<br>Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting | Drug: Diazoxide choline controlled-release tablet<br>* QD tablet formulation of choline salt of diazoxide<br>* Other names: DCCR;|
| Experimental: DCCR 300 mg fed<br>Administered a single 300 mg dose of DCCR after a standardized meal | Drug: Diazoxide choline controlled-release tablet<br>* QD tablet formulation of choline salt of diazoxide<br>* Other names: DCCR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | up to 24 hours |