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

Phase 1

Withdrawn

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Diazoxide choline; Drug: Diazoxide choline high dose

• Registration Number: NCT00901823
• Lead Sponsor: Essentialis, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Signed informed consent
• Healthy adults
• Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
• Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion Criteria

• Known CAD, DM, uncontrolled HTN
• Pregnancy or unable to complaint with the birth control method required

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Diazoxide choline	Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR
Sequence 2	Diazoxide choline high dose	Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

Primary Outcome Measures

Name	Time	Method
Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR	35 days

Secondary Outcome Measures

Name	Time	Method
Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions	35 days