HypertriglyceridemiaPhase 1NCT00901823
Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline
A Phase 1 study testing Diazoxide choline and Diazoxide choline high dose in people with Hypertriglyceridemia, run by Essentialis, Inc..
Trial 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. 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 and Diazoxide choline high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2011
- 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 adults
- Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
- Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL
Who cannot join
- Known CAD, DM, uncontrolled HTN
- Pregnancy or unable to complaint with the birth control method required
About this study
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
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- Diazoxide choline, Diazoxide choline high dose
- 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
A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
Diazoxide choline high doseDrug
A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR Receives: Drug: Diazoxide choline |
| Sequence 2 | Experimental | Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR Receives: Drug: Diazoxide choline high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR
Measured: 35 days
Secondary outcomes (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
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMar 2011
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: Did not support the planned development of DCCR in the new indication
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentialis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901823
- Sponsor's protocol ID
- PK010
- Status last verified
- Aug 2016
- First submitted
- 12 May 2009
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00901823
- Acronym / sponsor ID
- PK010
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not support the planned development of DCCR in the new indication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Essentialis, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 14 May 2009 (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, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Diazoxide cholineSingle dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR |
| Sequence 2 | Experimental | Drug: Diazoxide choline high doseSingle dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Healthy adults
- Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
- Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL
Key exclusion criteria (2 listed)
- Known CAD, DM, uncontrolled HTN
- Pregnancy or unable to complaint with the birth control method required
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 cholineA single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR | Drug | Sequence 1 |
| Diazoxide choline high doseA single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR | Drug | Sequence 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diazoxide choline and Diazoxide choline high dose in people with Hypertriglyceridemia, run by Essentialis, Inc..
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR (time frame: 35 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 1 Sep 2016.