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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prader-Willi Syndrome
• Intervention / Treatment: Drug: Diazoxide choline controlled-release tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Essentialis, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2017
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (ESTIMATE): September 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Prader-Willi Syndrome; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Diazoxide; Choline
• Other Study ID Numbers: PK024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED