Primary Objective: To evaluate the effect of single-dose TQ05105 on QTcF interval in healthy Chinese participants. Secondary Objectives: To evaluate the effects of single-dose TQ05105 on other cardiac parameters (heart rate, QT, RR, PR and QRS intervals) in healthy Chinese participants; To verify assay sensitivity by evaluating the effect of moxifloxacin on QTcF interval; To evaluate the safety and tolerability of single-dose TQ05105 in healthy Chinese participants; To characterize the pharmacokinetic (PK) characteristics of TQ05105 and its metabolite (TQ12550) after single administration of TQ05105 tablets in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
TQ05105 tablets are Janus kinase (JAK) inhibitors.
Placebo tablets contain no active substance.
Moxifloxacin Hydrochloride Tablets serve as positive control drug.
PKU Care Luzhong Hospital
Zibo, Shandong, China
Fridericia Placebo-Corrected Change from Baseline in QTc Interval (ΔΔQTcF)
Placebo \& baseline corrected ΔQTcF, core indicator to assess drug effect on ventricular repolarization.
Time frame: 60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
Heart Rate (HR)
Holter-derived heart rate
Time frame: 60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
PR interval (PR)
PR interval obtained via continuous Holter ECG monitoring
Time frame: 60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
RR interval (RR)
Holter-recorded RR interval
Time frame: 60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
Peak concentration (Cmax)
Maximum plasma drug concentration
Time frame: 1 hours before dosing, and at 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
Area under the plasma concentration-time curve ( AUC0-t)
The area enclosed by the blood concentration curve to the timeline
Time frame: 1 hours before dosing, and at 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
Plasma clearance (CL/F)
How much of the plasma is cleared per unit of time
Time frame: 1 hours before dosing, and at 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
Plasma elimination half-life (t1/2)
The time it takes for the terminal phase blood concentration to drop by half
Time frame: 1 hours before dosing, and at 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.
Adverse event rate
The occurrence of all adverse events (AEs), and serious adverse events (SAEs).
Time frame: 26 days after the first dose
Hematology
Abnormal hematology
Time frame: 26 days after the first dose
Serum biochemistry
Abnormal serum biochemistry
Time frame: 26 days after the first dose
Coagulation
Abnormal coagulation
Time frame: 26 days after the first dose
Urinalysis
Abnormal urinalysis
Time frame: 26 days after the first dose
Blood pressure
Abnormal blood pressure
Time frame: 26 days after the first dose
Pulse
Abnormal pulse
Time frame: 26 days after the first dose
Body temperature
Abnormal body temperature
Time frame: 26 days after the first dose
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