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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07229560

Enrollment

Registered

2025-11-17

Start date

2025-11-26

Completion date

2025-12-31

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGHRS-8080 Tablet

HRS-8080 tablet, specified dose on specified days.

DRUGItraconazole Capsule

Itraconazole capsule, specified dose on specified days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Clearance (CL/F) of HRS-8080.	From Day 1 to Day 11.
Time to maximum plasma concentration (Tmax) of HRS-8080.	From Day 1 to Day 11.
Serious adverse events (SAEs).	From Day 1 to Day 17.
Adverse events (AEs).	From Day 1 to Day 17.
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026