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.
Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and potential adverse reactions.
Patients (including partners) have no pregnancy plans or sperm/egg donation plans from screening until 6 months after the last dose of the investigational drug, and agree to use effective contraception.
Aged 18-75 years (inclusive), regardless of gender.
Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body mass index (BMI) = weight (kg)/height² (m²), with BMI ranging 18.0-32.0 kg/m² (inclusive).
History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by the investigator (except primary liver diseases and complications in participants with impaired liver function).
Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these processes.
Use of strong/moderate CYP3A4, CYP2C9, or CYP2C19 inducers/inhibitors within 4 weeks before screening.
Known hypersensitivity to TQ05105 tablet components or allergic constitution (e.g., allergy to ≥2 substances, drug allergy history, or prone to rash/eczema/asthma).
Parallel
TQ05105
DrugJanus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors
Peak concentration (Cmax)
Maximum plasma drug concentration of TQ05105 and TQ12550
Area under the concentration-time curve (AUC)
Area under the plasma concentration-time curve of TQ05105 and TQ12550
Time-to-maximum concentration( Tmax) of TQ05105 and TQ12550
Time-to-maximum concentration
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
Apparent volume of distribution (Vz/F)
Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability
Terminal elimination rate (λz)
First-order rate constant associated with the terminal (log-linear) elimination phase of TQ05105 and TQ12550
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