A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

NCT ID: NCT07229560

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-26
• Study Completion Date: 2025-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRS-8080 Tablets and Itraconazole Capsules Group

Group Type: EXPERIMENTAL

HRS-8080 Tablet

Intervention Type: DRUG

HRS-8080 tablet, specified dose on specified days.

Itraconazole Capsule

Intervention Type: DRUG

Itraconazole capsule, specified dose on specified days.

Interventions

HRS-8080 Tablet

HRS-8080 tablet, specified dose on specified days.

Intervention Type: DRUG

Itraconazole Capsule

Itraconazole capsule, specified dose on specified days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18-55 years;

2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;

3. Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;

4. Take contraception.

Exclusion Criteria

1. Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;

2. Severe infection, severe trauma or major surgery;

3. Any medications in the two weeks before screening or baseline period;

4. History of blood donation or severe blood loss;

5. Have been vaccinated within 3 months before the screening or baseline period;

6. History of smoking or excessive alcohol or drug abuse;

7. History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;

8. Other situations in which the researcher judges unsuitable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HRS-8080-105

Identifier Type: -

Identifier Source: org_study_id