This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Janus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong, China
NOT_YET_RECRUITINGPeak concentration (Cmax)
Maximum plasma drug concentration of TQ05105 and TQ12550
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the concentration-time curve (AUC)
Area under the plasma concentration-time curve of TQ05105 and TQ12550
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Time-to-maximum concentration( Tmax) of TQ05105 and TQ12550
Time-to-maximum concentration
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Plasma half life (t1/2)
The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half of TQ05105 and TQ12550
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration
Apparent volume of distribution (Vz/F)
Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration
Terminal elimination rate (λz)
First-order rate constant associated with the terminal (log-linear) elimination phase of TQ05105 and TQ12550
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Curve extrapolated to infinity (AUC_%Extrap)
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Percentage of the Area Under the Curve extrapolated to infinity
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Apparent Clearance (CL/F)
The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability
Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Fraction unbound(fu%)
The proportion of a drug or substance in the bloodstream that is not bound to plasma proteins and is therefore free to exert pharmacological activity, be metabolized, or undergo elimination.
Time frame: 0.5, 2, 6 hours after administration
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to day7