Once a day oral administration with DCCR is the optimal dosing regimen
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
9
DCCR 290 mg once a day for 10 days
Cetero
Fargo, North Dakota, United States
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
Time frame: 10 days
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)
Time frame: 10 days
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