HypertriglyceridemiaPhase 1NCT00688857
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
A Phase 1 study testing Diazoxide choline in people with Hypertriglyceridemia, run by Essentialis, Inc. at 1 site in United States.
Trial summary
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Diazoxide choline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2008
- 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
- Signed informed consent
- Healthy male and female subjects 18 to 75 years of age
- Body mass index (BMI) between 22-35 kg/m2
- Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
- Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
- Not pregnant
Who cannot join
- Significant underlying medical conditions
- Clinical laboratory test values outside the accepted range
- Smokers, tobacco users, or subjects currently using nicotine products
- Substance abuse
- History of allergic response(s) to diazoxide or related drugs
- Recent significant weight loss
- Use of medication affecting body weight, lipid or glucose metabolism
- Unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, 58104
About this study
Official title: A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
- Conditions
- Hypertriglyceridemia
- Being tested
- Diazoxide choline
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazoxide cholineDrug
Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
Diazoxide cholineDrug
Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Diazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16). Receives: Drug: Diazoxide choline |
| B | Experimental | Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16) Receives: Drug: Diazoxide choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
Measured: 16 days
Secondary outcomes (2)
Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions
Measured: Study days 8 and 16
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Measured: Entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essentialis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Investigators
- Alan K. Copa, Pharm. D., Principal investigator, PRACS Institute, Ltd. - Cetero Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688857
- Sponsor's protocol ID
- PK008
- Status last verified
- Nov 2010
- First submitted
- 28 May 2008
- Last updated
- 8 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00688857
- Acronym / sponsor ID
- PK008
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Essentialis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Jun 2008 (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.
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Diazoxide cholineDiazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16). |
| B | Experimental | Drug: Diazoxide cholineDiazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Healthy male and female subjects 18 to 75 years of age
- Body mass index (BMI) between 22-35 kg/m2
- Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
- Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
Key exclusion criteria (8 listed)
- Significant underlying medical conditions
- Clinical laboratory test values outside the accepted range
- Smokers, tobacco users, or subjects currently using nicotine products
- Substance abuse
- History of allergic response(s) to diazoxide or related drugs
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 cholineDiazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily | Drug | A |
| Diazoxide cholineDiazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily | Drug | B |
Primary outcome
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
Time frame: 16 days
2 secondary outcomes
Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions
Time frame: Study days 8 and 16
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Time frame: Entire study
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 8 Nov 2010.
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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, Pharm. D. principal investigator
PRACS Institute, Ltd. - Cetero Research
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 testing Diazoxide choline in people with Hypertriglyceridemia, 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 6 inclusion and 8 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 8 Nov 2010. 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?
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. (time frame: 16 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 8 Nov 2010.