A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Primary Purpose
Prader-Willi Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Diazoxide choline controlled-release tablet
Sponsored by
About this trial
This is an interventional treatment trial for Prader-Willi Syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
DCCR 75 mg fasted
DCCR 150 mg fasted
DCCR 300 mg fasted
DCCR 450 mg fasted
DCCR 300 mg fed
Arm Description
Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Administered a single 300 mg dose of DCCR after a standardized meal
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters: Cmax
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
AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Secondary Outcome Measures
Pharmacokinetic parameters: CL/F
CL/F derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Pharmacokinetic parameters: Tmax
Tmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02893618
Brief Title
A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Official Title
A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essentialis, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCCR 75 mg fasted
Arm Type
Experimental
Arm Description
Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Arm Title
DCCR 150 mg fasted
Arm Type
Experimental
Arm Description
Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Arm Title
DCCR 300 mg fasted
Arm Type
Experimental
Arm Description
Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Arm Title
DCCR 450 mg fasted
Arm Type
Experimental
Arm Description
Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
Arm Title
DCCR 300 mg fed
Arm Type
Experimental
Arm Description
Administered a single 300 mg dose of DCCR after a standardized meal
Intervention Type
Drug
Intervention Name(s)
Diazoxide choline controlled-release tablet
Other Intervention Name(s)
DCCR
Intervention Description
QD tablet formulation of choline salt of diazoxide
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters: Cmax
Description
Cmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose
Time Frame
up to 24 hours
Title
Pharmacokinetic parameters: AUC0-24
Description
AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters: CL/F
Description
CL/F derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Time Frame
up to 24 hours
Title
Pharmacokinetic parameters: Tmax
Description
Tmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
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