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.
Drug: Diazoxide choline controlled-release tablet
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Full eligibility criteria for NCT02893618
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
fasting glucose less than or equal to 100 mg/dL
HbA1c less than or equal to 6%
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
All locations for NCT02893618
View full eligibility
Tris trial is registered with FDA with number: NCT02893618. The sponsor of the trial is Essentialis, Inc. and it is looking for 32 volunteers for the current phase.
Official trial title: A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
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