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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02893618

Enrollment

Registered

2016-09-08

Start date

2017-07-31

Completion date

2017-12-31

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader-Willi Syndrome

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.

Interventions

DRUGDiazoxide choline controlled-release tablet

QD tablet formulation of choline salt of diazoxide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic parameters: Cmax	up to 24 hours	Cmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose
Pharmacokinetic parameters: AUC0-24	up to 24 hours	AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours

Secondary

Measure	Time frame	Description
Pharmacokinetic parameters: CL/F	up to 24 hours	CL/F derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Pharmacokinetic parameters: Tmax	up to 24 hours	Tmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026