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

NCT07229560 | Completed Phase 1

• 1 other identifier: HRS-8080-105
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax) of HRS-8080.

  From Day 1 to Day 11.

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.

  From Day 1 to Day 11.

• Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.

  From Day 1 to Day 11.

Secondary Outcomes (6)

• Time to maximum plasma concentration (Tmax) of HRS-8080.

  From Day 1 to Day 11.

• Terminal elimination half-life (t1/2) of HRS-8080.

  From Day 1 to Day 11.

• Apparent volume of distribution (Vz/F) of HRS-8080.

  From Day 1 to Day 11.

• Clearance (CL/F) of HRS-8080.

  From Day 1 to Day 11.

• Adverse events (AEs).

  From Day 1 to Day 17.

Study Arms (1)

HRS-8080 Tablets and Itraconazole Capsules Group

EXPERIMENTAL

Drug: HRS-8080 Tablet; Drug: Itraconazole Capsule

Interventions

HRS-8080 Tablet DRUG

HRS-8080 tablet, specified dose on specified days.

HRS-8080 Tablets and Itraconazole Capsules Group

Itraconazole Capsule DRUG

Itraconazole capsule, specified dose on specified days.

HRS-8080 Tablets and Itraconazole Capsules Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-55 years;
• Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;
• Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;
• Take contraception.

You may not qualify if:

• Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;
• Severe infection, severe trauma or major surgery;
• Any medications in the two weeks before screening or baseline period;
• History of blood donation or severe blood loss;
• Have been vaccinated within 3 months before the screening or baseline period;
• History of smoking or excessive alcohol or drug abuse;
• History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;
• Other situations in which the researcher judges unsuitable.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 26, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (1)