Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
1 other identifier
interventional
9
1 country
1
Brief Summary
Once a day oral administration with DCCR is the optimal dosing regimen
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 10, 2014
January 1, 2014
1 month
September 28, 2010
January 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Steady-state Pharmacokinetic profile of DCCR
* 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
10 days
Secondary Outcomes (1)
Concentration-Time profile of major metabolite
10 days
Study Arms (1)
DCCR Treatment
EXPERIMENTALDCCR Treatment 290 mg diazoxide choline
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL
- Fasting glucose ≤ 110 mg/dL
- HbA1c ≤ 6.0 %
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Essentialis, Inc.lead
- Cetero Research, San Antoniocollaborator
Study Sites (1)
Cetero
Fargo, North Dakota, 58104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan K Copa, PharmD
Cetero Research - Fargo, ND
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 30, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 10, 2014
Record last verified: 2014-01