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

NCT02893618 | Unknown Phase 2

• 1 other identifier: PK024
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prader-Willi Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pharmacokinetic parameters: CL/F

  up to 24 hours

• Pharmacokinetic parameters: Tmax

  up to 24 hours

Study Arms (5)

DCCR 75 mg fasted

EXPERIMENTAL

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

Drug: Diazoxide choline controlled-release tablet

DCCR 150 mg fasted

EXPERIMENTAL

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

Drug: Diazoxide choline controlled-release tablet

DCCR 300 mg fasted

EXPERIMENTAL

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

Drug: Diazoxide choline controlled-release tablet

DCCR 450 mg fasted

EXPERIMENTAL

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

Drug: Diazoxide choline controlled-release tablet

DCCR 300 mg fed

EXPERIMENTAL

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

Drug: Diazoxide choline controlled-release tablet

Interventions

Diazoxide choline controlled-release tablet DRUG

QD tablet formulation of choline salt of diazoxide

Also known as: DCCR

DCCR 150 mg fasted; DCCR 300 mg fasted; DCCR 300 mg fed; DCCR 450 mg fasted; DCCR 75 mg fasted

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Essentialis, Inc.: lead

MeSH Terms

Conditions

Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 8, 2016
• Study Start: July 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09