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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Essentialis, Inc.
• Treatments: Choline; Diazoxide

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