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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211860

Enrollment

Registered

2010-09-30

Start date

2010-10-31

Completion date

2010-11-30

Last updated

2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridmia

Keywords

DCCR, Diazoxide Chonline Controlled-Release Tablet = DCCR, Hypertriglyceridemia, Triglycerides, Pharmacokinetics

Brief summary

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.

Interventions

DRUGDiazoxide Choline Controlled-Release Tablet

DCCR 290 mg once a day for 10 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

Basic requirements 1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing 2. Body mass index (BMI) between 22 and 35 kg/m2 Specific laboratory test results 3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL 4. Fasting glucose ≤ 110 mg/dL 5. HbA1c ≤ 6.0 %

Exclusion criteria

Medications: recent, current, anticipated 1. 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) 2. Thiazide diuretics within 2 weeks prior to Screening Visit History of allergic reaction or significant intolerance to: 3. Diazoxide 4. Thiazides 5. Sulfonamides Lifestyle changes 6. Subjects intending to change exercise habits, and/or quit smoking Specific diagnoses, medical conditions and history 7. Known type I or III hyperlipidemia 8. Known type 1 DM 9. Known type 2 DM 10. 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 11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug

Design outcomes

Primary

Measure	Time frame	Description
Steady-state Pharmacokinetic profile of DCCR	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

Secondary

Measure	Time frame	Description
Concentration-Time profile of major metabolite	10 days	* 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026