A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects

Registration

Registration

NCT06562088

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

UNKNOWN

Enrollment

40

Start

2024-08-16

Primary completion

2024-11-19

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Conditions

Healthy Adult Subject

Interventions

DRUG:HDM1002 and rifampicin; DRUG:HDM1002 and itraconazole

Results posted

FALSE

Registered primary outcomes

• AUC[0-∞] of HDM1002 [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 [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 [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 [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 [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 [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 [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 [Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]