A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects
NCT Number: NCT06562088
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Adult Subject
Interventions: DRUG: HDM1002 and rifampicin|DRUG: HDM1002 and itraconazole
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2024-12-30
Locations: The second hospital of anhui medical university, Hefei, Anhui, China

Summary:
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.

Primary Outcome Measures: AUC[0-∞] of HDM1002, Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞, 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, 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, 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, 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, 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, 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, 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, Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Secondary Outcome Measures: AUC[0-∞] of HDM1002 metabolites, PK parameters : Area under the curve from time 0 hour to ∞, 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, 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, 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, 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, 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, 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, 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, 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, Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13