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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
Essentialis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 30, 2016
    Last Updated
    September 7, 2016
    Sponsor
    Essentialis, Inc.
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    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

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