Chronic Kidney Disease(CKD)Phase 1NCT06344936
Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects
A Phase 1 study testing HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules in people with Chronic Kidney Disease(CKD), run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- What is being tested?
- HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Jul 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign informed consent before the test, fully understand the test content, process and possible adverse reactions, and be willing to complete the study according to the requirements of the test plan;
- Healthy participants aged 18 to 45 years old (including both ends) on the date of signing the informed consent;
- Male participants weigh no less than 50kg, female participants weigh no less than 45kg, and body mass index (BMI) is in the range of 19.0~26.0 kg/m2 (including the cut-off value).
- The participant (including the partner) does not have a family plan and voluntarily takes the contraceptive measures specified in the program within 3 months after signing the informed consent letter to the last medication; Participants did not plan to donate sperm or eggs within 3 months after the end of the last dose.
Who cannot join
- Those who participated in blood donation and donated ≥400mL of blood within 3 months before taking the study drug, or received blood transfusion;
- Allergic constitution, including allergy related diseases (eczema, urticaria, allergic rhinitis, etc.), drug allergy or drug allergic reaction history; History of allergy to HRS-1780 tablets, itraconazole, rifampicin, rifamycin or its excipients;
- Have a history of drug and/or alcohol abuse, test positive for alcohol and drugs or have a history of drug abuse in the past five years or use of drugs in the three months prior to the test;
- Drinking more than 14 units of alcohol per week in the 6 months prior to screening (1 unit = 285mL for beer, 25mL for spirits, or 100mL for wine); Or have taken alcohol-containing products 48 hours before administration; Or positive alcohol breath test at baseline. ;
- Smoking more than 5 cigarettes per day in the 3 months before screening or use of any tobacco products 48 hours before dosing.
- Patients with abnormal vital signs, comprehensive physical examination, routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram, chest X-ray, abdominal B-ultrasonography and judged by the investigator to be clinically significant;
Show all 16Show fewer
- Medical history of major organ diseases, such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and skeletal musculoskeletal system, is not considered suitable for participation in this study;
- Patients with severe systemic infectious diseases, severe trauma or major surgical operations in the 3 months prior to screening and who plan to undergo surgery during the trial;
- Have participated in a clinical trial of any drug or medical device within 3 months or 5 half-lives prior to screening, whichever is longer, or plan to participate in a clinical trial of another drug or medical device during the trial period;
- Have taken any prescription or over-the-counter drugs in the 14 days prior to taking the study drug;
- HCV antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive;
- Women of childbearing age who have positive blood pregnancy tests at baseline;
- Pregnant and lactating women;
- Patients with a history of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection;
- Those who could not follow the dietary requirements during the trial;
- Subjects with other factors deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Assessment of the Effects of Itraconazole and Rifampicin on HRS-1780 Pharmacokinetics in Healthy Subjects
The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects
- Conditions
- Chronic Kidney Disease(CKD)
- Being tested
- HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1780 tablets; Itraconazole capsules; Rifampicin capsulesDrug
Treatment PartⅠ: Itraconazole capsule, 200mg QD, 7 times; HRS-1780 tablets, 10mg QD, twice Treatment PartⅡ: Rifampicin capsules, 600mg QD, 14 times; HRS-1780 tablets, 10mg QD, twice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Cmax of HRS-1780 in plasma.
Measured: About 3 days after the dose.
Assess the Tmax of HRS-1780 in plasma.
Measured: About 3 days after the dose.
Assess the t1/2 of HRS-1780 in plasma.
Measured: About 3 days after the dose.
Assess the AUC0-t of HRS-1780 in plasma.
Measured: About 3 days after the dose.
Assess the AUC0-inf of HRS-1780 in plasma.
Measured: About 3 days after the dose.
Secondary outcomes (1)
Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets.
Measured: About a month from the first medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies 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
- 28 participants (estimated)
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
- NCT06344936
- Sponsor's protocol ID
- HRS-1780-103
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Assessment of the Effects of Itraconazole and Rifampicin on HRS-1780 Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06344936
- Acronym / sponsor ID
- HRS-1780-103
- Conditions
- Chronic Kidney Disease(CKD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign informed consent before the test, fully understand the test content, process and possible adverse reactions, and be willing to complete the study according to the requirements of the test plan;
- Healthy participants aged 18 to 45 years old (including both ends) on the date of signing the informed consent;
- Male participants weigh no less than 50kg, female participants weigh no less than 45kg, and body mass index (BMI) is in the range of 19.0~26.0 kg/m2 (including the cut-off value).
- The participant (including the partner) does not have a family plan and voluntarily takes the contraceptive measures specified in the program within 3 months after signing the informed consent letter to the last medication; Participants did not plan to donate sperm or eggs within 3 months after the end of the last dose.
Key exclusion criteria (16 listed)
- Those who participated in blood donation and donated ≥400mL of blood within 3 months before taking the study drug, or received blood transfusion;
- Allergic constitution, including allergy related diseases (eczema, urticaria, allergic rhinitis, etc.), drug allergy or drug allergic reaction history; History of allergy to HRS-1780 tablets, itraconazole, rifampicin, rifamycin or its excipients;
- Have a history of drug and/or alcohol abuse, test positive for alcohol and drugs or have a history of drug abuse in the past five years or use of drugs in the three months prior to the test;
- Drinking more than 14 units of alcohol per week in the 6 months prior to screening (1 unit = 285mL for beer, 25mL for spirits, or 100mL for wine); Or have taken alcohol-containing products 48 hours before administration; Or positive alcohol breath test at baseline. ;
- Smoking more than 5 cigarettes per day in the 3 months before screening or use of any tobacco products 48 hours before dosing.
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-1780 tablets; Itraconazole capsules; Rifampicin capsulesTreatment PartⅠ: Itraconazole capsule, 200mg QD, 7 times; HRS-1780 tablets, 10mg QD, twice Treatment PartⅡ: Rifampicin capsules, 600mg QD, 14 times; HRS-1780 tablets, 10mg QD, twice | Drug | Group A |
Primary outcome
Assess the Cmax of HRS-1780 in plasma.
Time frame: About 3 days after the dose.
Assess the Tmax of HRS-1780 in plasma.
Time frame: About 3 days after the dose.
Assess the t1/2 of HRS-1780 in plasma.
Time frame: About 3 days after the dose.
Assess the AUC0-t of HRS-1780 in plasma.
Time frame: About 3 days after the dose.
Assess the AUC0-inf of HRS-1780 in plasma.
Time frame: About 3 days after the dose.
1 secondary outcome
Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets.
Time frame: About a month from the first medication.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Disease(CKD)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
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.
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-1780 tablets; Itraconazole capsules; Rifampicin capsules in people with Chronic Kidney Disease(CKD), 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 16 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Li (+86- 15618362889, na.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Cmax of HRS-1780 in plasma. (time frame: About 3 days after the dose.). The study lists 5 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 3 Apr 2024.