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

Essentialis

Status and phase: Unknown; Phase 2

Conditions: Prader-Willi Syndrome

Treatments: Drug: Diazoxide choline controlled-release tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02893618

PK024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 5 patient groups

DCCR 75 mg fasted

Experimental group

Description:

Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting

Treatment:

Drug: Diazoxide choline controlled-release tablet

DCCR 150 mg fasted

Experimental group

Description:

Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting

Treatment:

Drug: Diazoxide choline controlled-release tablet

DCCR 300 mg fasted

Experimental group

Description:

Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting

Treatment:

Drug: Diazoxide choline controlled-release tablet

DCCR 450 mg fasted

Experimental group

Description:

Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting

Treatment:

Drug: Diazoxide choline controlled-release tablet

DCCR 300 mg fed

Experimental group

Description:

Administered a single 300 mg dose of DCCR after a standardized meal

Treatment:

Drug: Diazoxide choline controlled-release tablet