NCT00901823

Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Essentialis, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Diazoxide choline	A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
DRUG	Diazoxide choline high dose	A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-05-14
• Last updated: 2016-09-01