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

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ClinicalTrials.gov Identifier: NCT00901823
Recruitment Status : Withdrawn (Did not support the planned development of DCCR in the new indication)
First Posted : May 14, 2009
Last Update Posted : September 1, 2016
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Diazoxide choline Drug: Diazoxide choline high dose Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2011
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Neil M Cowen, PhD/Chief Scientific Officer, Essentialis Inc.
ClinicalTrials.gov Identifier: NCT00901823     History of Changes
Other Study ID Numbers: PK010
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016

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