This is a Phase 1, single center, single dose, open-label clinical study to evaluate the pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy caucasian volunteers
The objective of this study is to determine the comparative pharmacokinetics, safety and tolerability of single oral dose of reformulated SHR6390 in healthy volunteers under fasting conditions. Each subject will receive a single dose of SHR6390, blood samples will be collected before dosing and at various time points up to 144 hours after drug administration, safety and the statistical analysis of the pharmacokinetic data will be obtained from this study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
a selective small-molecule CDK4/6 inhibitor
Linear Clinical Research
Melbourne, Western Australia, Australia
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: through study completion, an average of 1 year
Number of subjects with adverse events (AEs)
Time frame: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
Time frame: Screening up to study completion, an average of 1 year
Pharmacokinetic - Cmax
Maximum observed plasma concentration (Cmax) of SHR6390
Time frame: 7 days
Pharmacokinetic - AUC∞
Area under the concentration-time curve from time 0 to infinity of SHR6390
Time frame: 7 days
AUC from time 0 to the time of the last quantifiable concentration (AUClast) of SHR6390
Time frame: Day 1 pre-dose to Day 7 (144h) post-dose
Pharmacokinetic - AUClast
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Time frame: 7 days
Pharmacokinetic - Tmax
Time to Cmax of SHR6390
Time frame: 7 days
Pharmacokinetic - CL/F
Apparent clearance of SHR6390
Time frame: 7 days
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Pharmacokinetic - Vz/F
Apparent volume of distribution during terminal phase of SHR6390
Time frame: 7 days
Pharmacokinetic - t1/2
Terminal elimination half-life
Time frame: 7 days