The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered orally
Administered orally
The second hospital of anhui medical university
Hefei, Anhui, China
AUC[0-∞] of HDM1002
Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002
PK parameter : Area under the curve from time 0 to 24 hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002
PK parameter : Maximum observed concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002
PK parameters : Area under the curve from time 0 to t hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002
PK parameters : Time to maximum plasma concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002
PK parameters : Half life
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002
PK parameters : Apparent Clearance
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002
PK parameters : Apparent volume of distribution
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
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AUC[0-∞] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 hour to ∞
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 to 24 hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002 metabolites
PK parameters : Maximum observed concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 to t hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002 metabolites
PK parameters : Time to maximum plasma concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002 metabolites
PK parameters: Half life
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002 metabolites
PK parameters : Apparent Clearance
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002 metabolites
PK parameters : Apparent volume of distribution
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Adverse events (AEs)
Number of subjects reporting AEs
Time frame: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13