Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline
Phase 1
Withdrawn
- Conditions
- Hypertriglyceridemia
- Interventions
- Registration Number
- NCT00901823
- Lead Sponsor
- Essentialis, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Diazoxide choline Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR Sequence 2 Diazoxide choline high dose Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR
- Primary Outcome Measures
Name Time Method Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR 35 days
- Secondary Outcome Measures
Name Time Method 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 35 days