This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
TQB3454 is a Isocitrate dehydrogenase 1 (IDH1) mutation inhibitor.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Peak concentration (Cmax)
Maximum plasma drug concentration
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Area under the time-concentration curve from 0 to t hours (AUC0-t)
Area under the plasma concentration-time curve from the time of first dose to the time of the last measurable concentration.
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Area under the time-concentration curve from 0 to infinity (AUC0-∞)
Area under the plasma concentration-time curve from the time of first dose extrapolated to infinity
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Time to peak (Tmax)
Time to reach maximum plasma concentration after drug administration
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Elimination half-life (t1/2)
The time it takes for the blood concentration of a drug to decrease from its highest value to half in the body.
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Apparent volume of distribution (Vd/F)
The ratio of the amount of drug in the body to the concentration in the blood.
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Apparent clearance (CL/F)
Apparent total clearance of the drug from plasma after oral administration.
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Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Elimination rate constant (λz)
Terminal disposition rate constant/terminal rate constant
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Lag time (tlag)
The time required from the start of administration to the appearance of the drug in the blood.
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Percentage of residual area (AUC% Extrap)
Residual area as a percentage of the entire area under curve.
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Adverse event rate
The incidence of adverse events (AEs), abnormal laboratory test values, and severe adverse events (SAEs).
Time frame: Before the first administration to 360 hours after the last administration.
Adverse event severity
The severity of adverse events (AEs), abnormal laboratory test values, and severe adverse events (SAEs).
Time frame: Before the first administration to 360 hours after the last administration.