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

Sponsor:	Essentialis, Inc.
Information provided by:	Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT00901823

Purpose

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.

Condition	Intervention	Phase
Hypertriglyceridemia	Drug: Diazoxide choline Drug: Diazoxide choline high dose	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides

Drug Information available for: Choline Choline chloride Choline dihydrogen citrate Choline bitartrate Diazoxide Choline salicylate

U.S. FDA Resources

Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:

Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sequence 1 Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR	Drug: Diazoxide choline A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
Experimental: Sequence 2 Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple 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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901823

Contacts

Contact: Gloria C Lin, PhD	858-964-5013	gloria.lin@essentialistherapeutics.com
Contact: Neil M Cowen, PhD	858-964-5008	nmcowen@essentialistherapeutics.com

Locations

United States, California
TBD	Not yet recruiting
TBD, California, United States
Contact: NA

Sponsors and Collaborators

Essentialis, Inc.

More Information

No publications provided

Responsible Party:	Neil M Cowen, PhD/Chief Scientific Officer, Essentialis Inc.
ClinicalTrials.gov Identifier:	NCT00901823 History of Changes
Other Study ID Numbers:	PK010
Study First Received:	May 12, 2009
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Choline
Diazoxide
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012