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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00901823
• Other study ID #: PK010
• Status: Withdrawn
• Phase: Phase 1
• First received: May 12, 2009
• Last updated: August 30, 2016
• Start date: March 2011
• Est. completion date: March 2011

Study information

• Verified date: August 2016
• Source: Essentialis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Diazoxide choline
A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
• Diazoxide choline high dose
A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Locations

Country	Name	City	State
United States	TBD	TBD	California

Sponsors (1)

Lead Sponsor	Collaborator
Essentialis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR		35 days	No
Secondary	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	No