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

Prader-Willi Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02893618
• Other study ID #: PK024
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 30, 2016
• Last updated: September 7, 2016
• Start date: July 2017
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Essentialis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prader-Willi Syndrome

Intervention

Drug:
• Diazoxide choline controlled-release tablet
QD tablet formulation of choline salt of diazoxide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Essentialis, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No