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

NCT ID: NCT02893618

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Prader-Willi Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCCR 75 mg fasted

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

Group Type: EXPERIMENTAL

Diazoxide choline controlled-release tablet

Intervention Type: DRUG

QD tablet formulation of choline salt of diazoxide

DCCR 150 mg fasted

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

Group Type: EXPERIMENTAL

Diazoxide choline controlled-release tablet

Intervention Type: DRUG

QD tablet formulation of choline salt of diazoxide

DCCR 300 mg fasted

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

Group Type: EXPERIMENTAL

Diazoxide choline controlled-release tablet

Intervention Type: DRUG

QD tablet formulation of choline salt of diazoxide

DCCR 450 mg fasted

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

Group Type: EXPERIMENTAL

Diazoxide choline controlled-release tablet

Intervention Type: DRUG

QD tablet formulation of choline salt of diazoxide

DCCR 300 mg fed

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

Group Type: EXPERIMENTAL

Diazoxide choline controlled-release tablet

Intervention Type: DRUG

QD tablet formulation of choline salt of diazoxide

Interventions

Diazoxide choline controlled-release tablet

QD tablet formulation of choline salt of diazoxide

Intervention Type: DRUG

Other Intervention Names

DCCR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essentialis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PK024

Identifier Type: -

Identifier Source: org_study_id