This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule. This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control. This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
300 mg,single dose.
400 mg, single dose.
Peking University Third Hospital
Beijing, Beijing Municipality, China
ΔΔQTcF
The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
Time frame: 2hours before administration and 48hours and 192hours after administration
adverse events
The number, frequency and incidence of adverse events
Time frame: Trial period to day 21 after administration
Physical examination
Descriptive statistics on physical examination indicators visited and their changes from baseline
Time frame: From 1 day before administration to 21 days after administration
Axillary temperature
Descriptive statistics of vital signs at each visit and their change from baseline
Time frame: From 2.0 hours before administration to 21 days after administration
blood pressure
Descriptive statistics of vital signs at each visit and their change from baseline
Time frame: From 2.0 hours before administration to 21 days after administration
pulse
Descriptive statistics of vital signs at each visit and their change from baseline
Time frame: From 2.0 hours before administration to 21 days after administration
Ecg monitoring and electrocardiogram
QTcF
Time frame: Trial period to day 21 after administration
laboratory examination
Descriptive statistics were collected for each laboratory indicator visited and its change from baseline
Time frame: Trial period to day 21 after administration
Plasma concentration and pharmacokinetic parameters
Cmax
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
AUC0-t
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
AUC0-∞
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
Tmax
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
T1/2
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
CL/F
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
VZ/F
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
MRT
Time frame: 60 minutes before dosing to day 9 after dosing
Plasma concentration and pharmacokinetic parameters
AUC\_%Extrap
Time frame: 60 minutes before dosing to day 9 after dosing
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