A Phase 1, Single-Dose, Non-Randomized, Open Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of DZD9008

简要总结

主要结局

次要结局

• Terminal phase half-life (t1/2),(Day 1 to day 14)
• Adverse events(Day 1 to day 14)
• Apparent total body clearance (CL/F)(Day 1 to day 14)
• Unbound area under plasma concentration time curve from zero to infinity (AUC0-inf, u)(Day 1 to day 14)
• Unbound maximum observed plasma (peak) drug concentration (Cmax, u)(Day 1 to day 14)
• Unbound apparent total body clearance (CLu/F)(Day 1 to day 14)
• Unbound apparent volume of distribution (Vz,u/F)(Day 1 to day 14)
• Clinical laboratory test results: hematology, coagulation, serum chemistry, urinalysis(Day 1 to day 14)
• Unbound area under the plasma concentration-curve from time zero to last quantifiable concentration (AUC0-last, u)(Day 1 to day 14)
• Area under plasma concentration time curve from zero to infinity (AUCinf)(Day 1 to day 14)
• Time to maximum observed plasma concentration (Tmax)(Day 1 to day 14)
• Fraction unbound (Fu)(Day 1 to day 14)
• 12-lead ECG results: tracings, rhythm, RR interval, PR interval, QRS width, QT interval, and QTcF(Day 1 to day 14)
• Vital sign measurements: systolic and diastolic blood pressure, pulse rate, respiratory rate and body temperature(Day 1 to day 14)
• Physical examination findings: assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities(Day 1 to day 14)