A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36
DDI of HEC585 andNintedanib:Nintedanib,twice a day,D1-D7 and D30-D36
DDI of HEC583 and Pirfenidone: Pirfenidone:three times a day,D1-D3 and D25-D27
Shanghai Xuhui Central Hospital
Shanghai, China
Area under the curve from 0 to 24 hours [AUC (0~24)]
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
Time frame: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Maximum Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
Time frame: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Area under the curve from 0 to 24 hours [AUC (0~24)]
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib
Time frame: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Observed Plasma Concentration (Cmax)
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
Time frame: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
Time frame: up to 31 days(HEC585 and Pirfenidone)
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
Time frame: up to 40 days(HEC585 and Nintedanib)
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