NCT06601517

A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.

A Phase I, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of HDM1002 on the Pharmacokinetics of Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy and Overweight Adult Chinese Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.

Conditions

• Healthy Adult Subject
• Overweight Subject

Interventions

Type	Name	Description
DRUG	Repaglinide	Single dose; Administered orally
DRUG	Atorvastatin	Single dose; Administered orally
DRUG	Digoxin	Single dose; Administered orally
DRUG	Rosuvastatin	Single dose; Administered orally
DRUG	HDM1002	Administered orally

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-02-01
• Completion: 2025-04-01
• First posted: 2024-09-19
• Last updated: 2024-09-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study