The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects
This will be a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts. Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Up to 48 subjects will be studied in up to 6 groups (Groups A1 to A6), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours postdose), except for Group A3, which will participate in a second treatment period for a food effect evaluation. Each subject in Group A3 will participate in 2 treatment periods separated by a minimum of 7 days. Dosing of subjects in the fed state in Group A3 can commence after review of the safety data from Group A4. Part B will comprise a multiple-dose, sequential-group study. Up to 36 subjects will be studied in up to 3 groups (Groups B1 to B3), with each group consisting of 12 subjects. Part B of the study may start after completion of Group A5, at a dose equal or less than given in Groups A1 to A3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound.
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States
Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
(AUC0-∞)
area under the plasma concentration-time curve (AUC) from time zero to infinity
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h
tmax
time of the maximum observed plasma concentration
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
Vz/F
apparent volume of distribution
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h
t½
apparent terminal elimination half-life
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
CL/F
apparent oral clearance
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
Adverse event
To assess the safety and tolerability of 7 days therapy.
Time frame: From baseline to 7 days
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