- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901823
Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline
August 30, 2016 updated by: Essentialis, Inc.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
35 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
35 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
March 1, 2011
Study Completion (Anticipated)
March 1, 2011
Study Registration Dates
First Submitted
May 12, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 14, 2009
Study Record Updates
Last Update Posted (Estimate)
September 1, 2016
Last Update Submitted That Met QC Criteria
August 30, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypertriglyceridemia
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Antimetabolites
- Gastrointestinal Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Nootropic Agents
- Lipotropic Agents
- Diazoxide
- Choline
Other Study ID Numbers
- PK010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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