Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects - Full Text View

Sponsor:	Essentialis, Inc.
Collaborator:	Cetero Research, San Antonio
Information provided by:	Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT01211860

Purpose

Once a day oral administration with DCCR is the optimal dosing regimen

Condition	Intervention	Phase
Hypertriglyceridmia	Drug: Diazoxide Choline Controlled-Release Tablet	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels

Resource links provided by NLM:

Drug Information available for: Choline bitartrate Diazoxide

U.S. FDA Resources

Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:

Steady-state Pharmacokinetic profile of DCCR [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Mean concentration-time profile for diazoxide
- Steady-state pharmacokinetic parameters of diazoxide (Cmax(ss), AUC0-inf(ss), and CL/F)
- Terminal elimination half-life (t½) of diazoxide

Secondary Outcome Measures:

Concentration-Time profile of major metabolite [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Steady-state pharmacokinetic parameters (Cmax(ss) and AUC0-inf(ss)) of the major metabolite of diazoxide
- Terminal elimination half-life (t½) of the major metabolite of diazoxide
- Metabolite-to-parent ratios at steady-state in terms of Cmax(ss) and AUC0-inf(ss)

Estimated Enrollment:	10
Study Start Date:	October 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DCCR Treatment DCCR Treatment 290 mg diazoxide choline	Drug: Diazoxide Choline Controlled-Release Tablet DCCR 290 mg once a day for 10 days

Detailed Description:

POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit.

Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.

Eligibility

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

Criteria

Inclusion Criteria:

- Basic requirements

Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing
Body mass index (BMI) between 22 and 35 kg/m2

Specific laboratory test results 3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL 4. Fasting glucose ≤ 110 mg/dL 5. HbA1c ≤ 6.0 %

Exclusion Criteria:

- Medications: recent, current, anticipated

Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
Thiazide diuretics within 2 weeks prior to Screening Visit

History of allergic reaction or significant intolerance to:
Diazoxide
Thiazides
Sulfonamides

Lifestyle changes
Subjects intending to change exercise habits, and/or quit smoking

Specific diagnoses, medical conditions and history
Known type I or III hyperlipidemia
Known type 1 DM
Known type 2 DM
Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator

Specific laboratory test results
Any relevant biochemical abnormality interfering with the assessments of the investigational drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211860

Locations

United States, North Dakota
Cetero
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Essentialis, Inc.

Cetero Research, San Antonio

Investigators

Principal Investigator:

Alan K Copa, PharmD

Cetero Research - Fargo, ND

More Information

No publications provided

Responsible Party:	Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT01211860 History of Changes
Other Study ID Numbers:	PK015
Study First Received:	September 28, 2010
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Essentialis, Inc.:

DCCR
Diazoxide Chonline Controlled-Release Tablet = DCCR
Hypertriglyceridemia
Triglycerides
Pharmacokinetics

Additional relevant MeSH terms:

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 May 24, 2012