Clinical Trial: NCT07229560
A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Shandong Suncadia Medicine Co., Ltd. |
| Information Provided By: | Shandong Suncadia Medicine Co., Ltd. |
| Last Update Posted: | 2026-01-14 |
Study Overview
Brief Summary
This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.
Official Title
The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study
Conditions
Breast Cancer
Intervention / Treatment
- Drug: HRS-8080 Tablet
- Drug: Itraconazole Capsule
Other Study ID Numbers
- HRS-8080-105
Start Date (Actual)
2025-11-26
Primary Completion Date (Actual)
2025-12-31
Study Completion Date (Actual)
2025-12-31
Enrollment (Actual)
16
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Shandong Suncadia Medicine Co., Ltd. |
| Information Provided By: | Shandong Suncadia Medicine Co., Ltd. |
| Last Update Posted: | 2026-01-14 |
Study Overview
Brief Summary
This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.
Official Title
The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study
Conditions
Breast Cancer
Intervention / Treatment
- Drug: HRS-8080 Tablet
- Drug: Itraconazole Capsule
Other Study ID Numbers
- HRS-8080-105
Start Date (Actual)
2025-11-26
Primary Completion Date (Actual)
2025-12-31
Study Completion Date (Actual)
2025-12-31
Enrollment (Actual)
16
Study Type
Interventional
Phase
Phase 1