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

Essentialis, Inc.0 sites32 target enrollmentStarted: July 2017Last updated: September 9, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Sponsor: Essentialis, Inc.
Enrollment: 32
Primary Endpoint: Pharmacokinetic parameters: Cmax

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: 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