Breast CancerPhase 1NCT07229560
A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants
A Phase 1 study testing HRS-8080 Tablet and Itraconazole Capsule in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-8080 Tablet and Itraconazole Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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
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
- Being tested
- HRS-8080 Tablet, Itraconazole Capsule
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8080 TabletDrug
HRS-8080 tablet, specified dose on specified days.
Itraconazole CapsuleDrug
Itraconazole capsule, specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| HRS-8080 Tablets and Itraconazole Capsules Group | Experimental | Not described Receives: Drug: HRS-8080 Tablet; Drug: Itraconazole Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of HRS-8080.
Measured: 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.
Measured: From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.
Measured: From Day 1 to Day 11.
Secondary outcomes (6)
Time to maximum plasma concentration (Tmax) of HRS-8080.
Measured: From Day 1 to Day 11.
Terminal elimination half-life (t1/2) of HRS-8080.
Measured: From Day 1 to Day 11.
Apparent volume of distribution (Vz/F) of HRS-8080.
Measured: From Day 1 to Day 11.
Clearance (CL/F) of HRS-8080.
Measured: From Day 1 to Day 11.
Adverse events (AEs).
Measured: From Day 1 to Day 17.
Serious adverse events (SAEs).
Measured: From Day 1 to Day 17.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start26 Nov 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229560
- Sponsor's protocol ID
- HRS-8080-105
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07229560
- Acronym / sponsor ID
- HRS-8080-105
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-8080 Tablets and Itraconazole Capsules Group | Experimental | Drug: HRS-8080 Tablet, Drug: Itraconazole Capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-8080 TabletHRS-8080 tablet, specified dose on specified days. | Drug | HRS-8080 Tablets and Itraconazole Capsules Group |
| Itraconazole CapsuleItraconazole capsule, specified dose on specified days. | Drug | HRS-8080 Tablets and Itraconazole Capsules Group |
Primary outcome
Maximum concentration (Cmax) of HRS-8080.
Time frame: 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.
Time frame: From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.
Time frame: From Day 1 to Day 11.
6 secondary outcomes
Time to maximum plasma concentration (Tmax) of HRS-8080.
Time frame: From Day 1 to Day 11.
Terminal elimination half-life (t1/2) of HRS-8080.
Time frame: From Day 1 to Day 11.
Apparent volume of distribution (Vz/F) of HRS-8080.
Time frame: From Day 1 to Day 11.
Clearance (CL/F) of HRS-8080.
Time frame: From Day 1 to Day 11.
Adverse events (AEs).
Time frame: From Day 1 to Day 17.
Serious adverse events (SAEs).
Time frame: From Day 1 to Day 17.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-8080 Tablet and Itraconazole Capsule in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) of HRS-8080. (time frame: From Day 1 to Day 11.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.