The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Single dose of HDM1002 will be administered on Day 1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGMaximum Plasma Concentration (Cmax)
Maximum observed plasma of HDM1002 concentration.
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to infinite time.
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t)
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Fraction of Unbound Drug in Plasma (fu)
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
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