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Trials / Recruiting

RecruitingNCT06710990

Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.

Conditions

Interventions

TypeNameDescription
DRUGSHR-A1811SHR-A1811
DRUGRitonavirRitonavir
DRUGItraconazoleItraconazole

Timeline

Start date
2025-02-17
Primary completion
2025-06-01
Completion
2026-08-01
First posted
2024-12-02
Last updated
2025-03-28

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06710990. Inclusion in this directory is not an endorsement.

Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects Wi (NCT06710990) · Clinical Trials Directory