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

Sponsor
Essentialis, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02893618
Collaborator
(none)
32
Enrollment
5
Arms
5
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Diazoxide choline controlled-release tablet
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: DCCR 75 mg fasted

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

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

    		•
    Experimental: DCCR 150 mg fasted

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

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

    		•
    Experimental: DCCR 300 mg fasted

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

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

    		•
    Experimental: DCCR 450 mg fasted

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

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

    		•
    Experimental: DCCR 300 mg fed

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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 Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Essentialis, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Essentialis, Inc.
    ClinicalTrials.gov Identifier:
    NCT02893618
    Other Study ID Numbers:
    • PK024
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Sep 9, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Prader-Willi Syndrome
    Diazoxide
    Choline

    Study Results

    No Results Posted as of Sep 9, 2016