The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Tasurgratinib oral tablet.
Tasurgratinib oral capsule.
Eisai Trial Site #6
Hakata, Fukuoka, Japan
RECRUITINGEisai Trial Site #4
Kurume, Fukuoka, Japan
TERMINATEDEisai Trial Site #2
Yuhu, Oita Prefecture, Japan
Cmax: Maximum Observed Plasma Concentration of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose
AUC(0-t): Area Under the Plasma Concentration versus Time Curve from Time 0 to Time of Last Quantifiable Concentration of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose
AUC(0-inf): Area Under the Plasma Concentration versus Time Curve from Time 0 to Infinity of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose
Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite
Time frame: Day 1: 0-144 hours postdose
AUC(0-72Hours): Area Under the Plasma Concentration versus Time Curve from Time 0 to 72 Hours of Tasurgratinib and its Metabolite
Time frame: Day 1: 0-144 hours postdose
T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite
Time frame: Day 1: 0-144 hours postdose
CL/F: Apparent Total Body Clearance of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose
Vz/F : Apparent Volume of Distribution at Terminal Phase of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose
AUC Metabolite Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of Tasurgratinib, Corrected for Molecular Weights
Time frame: Day 1: 0-144 hours postdose
fu: Plasma Protein Unbound Fraction of Tasurgratiniband its Metabolite
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Eisai Trial Site #3
Bukyo-ku, Tokyo, Japan
RECRUITINGEisai Trial Site #1
Mintato-ku, Tokyo, Japan
RECRUITINGEisai Trial Site #8
Shinjuku-ku, Tokyo, Japan
RECRUITINGEisai Trial Site #5
Kofu, Yamanashi, Japan
RECRUITINGEisai Trial Site #7
Kyoto, Japan
RECRUITINGTime frame: Day 1: 0-144 hours postdose
AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose
CLu/F: Apparent Clearance Relative to the Unbound Plasma Concentration of Based on AUCu of Tasurgratinib
Time frame: Day 1: 0-144 hours postdose