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

This study has been withdrawn prior to enrollment.
(Did not support the planned development of DCCR in the new indication)
Sponsor:
Information provided by:
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT00901823
First received: May 12, 2009
Last updated: August 30, 2016
Last verified: August 2016
  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 1

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:


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 ]

Enrollment: 0
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
TBD
TBD, California, United States
Sponsors and Collaborators
Essentialis, Inc.
  More Information

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: August 30, 2016
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
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 23, 2016