HypertriglyceridmiaPhase 1NCT01211860
Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
A Phase 1 study of Hypertriglyceridmia, run by Essentialis, Inc. at 1 site in United States.
Trial summary
Once a day oral administration with DCCR is the optimal dosing regimen Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridmia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 %
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
Once a day oral administration with DCCR is the optimal dosing regimen
Read the 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.
- Conditions
- Hypertriglyceridmia
- Being tested
- Diazoxide Choline Controlled-Release Tablet
- Keywords
- DCCR, Diazoxide Chonline Controlled-Release Tablet = DCCR, Hypertriglyceridemia, Triglycerides, Pharmacokinetics
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazoxide Choline Controlled-Release TabletDrug
DCCR 290 mg once a day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| DCCR Treatment | Experimental | DCCR Treatment 290 mg diazoxide choline Receives: Drug: Diazoxide Choline Controlled-Release Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (1)
Concentration-Time profile of major metabolite
- 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)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentialis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Responsible party
- Sponsor
- Investigators
- Alan K Copa, PharmD, Principal investigator, Cetero Research - Fargo, ND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211860
- Sponsor's protocol ID
- PK015
- Status last verified
- Jan 2014
- First submitted
- 28 Sep 2010
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
- ClinicalTrials.gov ID
- NCT01211860
- Acronym / sponsor ID
- PK015
- Conditions
- Hypertriglyceridmia
- Keywords
- DCCR, Diazoxide Chonline Controlled-Release Tablet = DCCR, Hypertriglyceridemia, Triglycerides, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Essentialis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Once a day oral administration with DCCR is the optimal dosing regimen
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCCR Treatment | Experimental | Drug: Diazoxide Choline Controlled-Release TabletDCCR Treatment 290 mg diazoxide choline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
- Diazoxide
- Thiazides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazoxide Choline Controlled-Release TabletDCCR 290 mg once a day for 10 days | Drug | DCCR Treatment |
Primary outcome
Steady-state Pharmacokinetic profile of DCCR
Time frame: 10 days
* 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
1 secondary outcome
Concentration-Time profile of major metabolite
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan K Copa, PharmD principal investigator
Cetero Research - Fargo, ND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Hypertriglyceridmia, run by Essentialis, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady-state Pharmacokinetic profile of DCCR (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.