This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and without food.
The food effect study will be an open-label, 2-sequence, balanced crossover design in 12 subjects previously untreated with CT-044. Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing and remain in house until Day 3. Each subject will receive CT-044 single oral dose once under fed conditions (i.e., a high fat meal per FDA recommendations) and once in the fasted state. 9 Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up. Subjects will return to the Clinical Trial Unit to be treated by the second sequence after a washout period of at least 7 days, but no more than 14 days. All procedures will be repeated for the second treatment sequence. When possible, the procedures conducted at the 144-hour follow-up visit for the first sequence may serve as baseline for the second sequence of the crossover.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CT-044 HCl is a reactive species decomposition accelerant
Lotus Clinical Resarch,LLC
Pasadena, California, United States
Comparison of the maximum drug concentration
Following administration with and without food (Cmax) of oral single dose of CT-044
Time frame: 7 days
Comparison of the Time of maximum drug concentration (tmax)
Following a single oral dose of CT-044 following administration with and without food
Time frame: 7 days
Comparison of the Area under the drug concentration Time curve from time 0 extrapolated to infinity (AUC0-∞)
Following a single oral dose of CT-044 following administration with and without food
Time frame: 7 days
Comparison of the Area under the drug concentration Time curve from time 0 to the time of the last quantifiable concentration (AUC0-last)
Following a single oral dose of CT-044 following administration with and without food
Time frame: 7 days
Comparison of the Apparent oral clearance (CL/F)
Following a single oral dose of CT-044 following administration with and without food
Time frame: 7 days
Comparison of the Apparent volume distribution (Vz/F)
Following a single oral dose of CT-044 following administration with and without food
Time frame: 7 days
Comparison of the Terminal half-life (t1/2)
Following a single oral dose of CT-044 following administration with and without food
Time frame: 7 days
Comparison of the Terminal rate constant (λz)
Following a single oral dose of CT-044 following administration with and without food
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Time frame: 7 days
Comparison of the Relative bioavailability
Following a single oral dose of CT-044 after administration of a high-fat meal (F)
Time frame: 7 days
Peak Plasma Concentration (Cmax)
Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction on the Peak Plasma Concentration (Cmax)
Time frame: 7 days
Plasma concentration versus time curve (AUC)
Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction Area under the plasma concentration versus time curve (AUC)
Time frame: 7 days