Advanced Solid TumorPhase 1NCT06198556
Effect of Rifampicin on the Pharmacokinetics of HRS-1167 in Healthy Subjects
A Phase 1 study testing HRS-1167 tablets; rifampicin in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy adult subjects after oral administration of HRS-1167 tablets. The secondary objective of the study is to evaluate the safety of HRS-1167 alone and when co-administered with rifampicin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HRS-1167 tablets; rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2024to 5 Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects aged 18 to 50 years old at the date of signing the informed consent;
- Weight ≥ 50 kg for male, weight ≥ 45 kg for female, body mass index (BMI): 19~28 kg/m2 (including critical value);
- Female patients of childbearing age who are not surgically sterilized and male patients whose partners are women of childbearing age must use highly effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of HRS-1167; female patients of childbearing age who are not surgically sterilized must have a negative serum HCG test within 7 days before the first dose, and must be non-lactating;
- Be able to communicate well with the investigators and understand and comply with the requirements in this study.
Who cannot join
- History of or currently suffering from any serious clinical diseases such as diseases in circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases may interfere with the test results
- Any surgery within 6 months before screening, or plan to perform surgery during the study period, or who have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, gastric reduction surgery, etc.);
- Those who donate blood or other reasons of bleeding cause the total loss of blood more than 400mL, or receive blood transfusions, or used blood products within 3 months before screening;
- Allergic constitution, including severe drug allergy or history of drug allergy; Have allergic history to HRS-1167 tablets, rifampicin, rifamycin or their accessories;
- Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 1 year prior to screening; Positive for urine drug abuse screening test;
- Have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin, etc.) for a long time (continuous administration for more than 7 days) within 6 months before screening;
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- Those who have participated in any clinical trials and taken study drugs within 3 months before the first administration;
- Have used any drugs that effect enzyme activity within 28 days prior to taking the study drug;
- Used any prescription drugs and Chinese medicines within one month before the first administration; Have used any over-the-counter drugs (OTC) or food supplements (including vitamins and calcium tablets, etc.) within 2 weeks prior to the first administration;
- Those who smoke more 5 cigarettes per day in the 3 months before screening or those who do not agree to quit smoking during the test, or those who are positive for urine nicotinic screen;
- Alcohol abuse in the 6 months prior to screening, with an average weekly intake of more than 14units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine), and those who cannot abstain from alcohol during the trial, or those who have a positive alcohol breath screening;
- The results of vital signs, physical examination, 12-lead electrocardiogram, B-ultrasound, chest X-ray, blood-routine examination, blood biochemistry, urine-routine examination, and coagulation function are abnormal during the screening and judged by the research doctor as clinically significant.
- Those who are positive for HBsAg, HCV antibody, syphilis antibody and HIV antibody.
- From 48 hours before taking the study drug to the end of the study, subjects have xanthine-rich beverages (chocolate, coffee, tea, etc.) or food; From 7 days before taking the study drug to the end of the study, subjects have; Can't comply with the unified dietary arrangement or have special requirements for diet;
- Who have blood phobia and faint with acupuncture; or those with poor vascular conditions, inability to embed needles or inability to tolerate venipuncture;
- Pregnant and lactating women;
- Subjects who are judged by researchers to be unsuitable for participating in this test.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
About this study
Official title: A Single Center, Single Arm, Open, Fixed Sequence Study on the Pharmacokinetic Effects of Rifampicin on Oral Administration of HRS-1167 in Healthy Subjects
The primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy adult subjects after oral administration of HRS-1167 tablets. The secondary objective of the study is to evaluate the safety of HRS-1167 alone and when co-administered with rifampicin.
- Conditions
- Advanced Solid Tumor
- Being tested
- HRS-1167 tablets; rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1167 tablets; rifampicinDrug
HRS-1167 tablets single oral dose of HRS-1167 or co-administered with rifampicin.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1167 with rifampicin | Experimental | Not described Receives: Drug: HRS-1167 tablets; rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of HRS1167: Cmax
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: AUC0-t
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: AUC0-inf
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Secondary outcomes (5)
Pharmacokinetics parameters of HRS1167: Tmax
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: t1/2
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: λz
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: AUC_%Extrap
Measured: Based on pre-dose, 0-72 hours post-dose sampling times
Incidence and severity of adverse events/serious adverse events (base on CTCAE 5.0)
Measured: From Day 1 to Day 24 after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start14 Jan 2024
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui 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
- Model description
- Compare the pharmacokinetic effects of Rifampicin on HRS-1167 in healthy subjects.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198556
- Sponsor's protocol ID
- HRS-1167-102
- Status last verified
- Feb 2024
- First submitted
- 27 Dec 2023
- Last updated
- 28 Feb 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single Arm, Open, Fixed Sequence Study on the Pharmacokinetic Effects of Rifampicin on Oral Administration of HRS-1167 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06198556
- Acronym / sponsor ID
- HRS-1167-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 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 primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy adult subjects after oral administration of HRS-1167 tablets. The secondary objective of the study is to evaluate the safety of HRS-1167 alone and when co-administered with rifampicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Compare the pharmacokinetic effects of Rifampicin on HRS-1167 in healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| HRS-1167 with rifampicin | Experimental | Drug: HRS-1167 tablets; rifampicin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult subjects aged 18 to 50 years old at the date of signing the informed consent;
- Weight ≥ 50 kg for male, weight ≥ 45 kg for female, body mass index (BMI): 19~28 kg/m2 (including critical value);
- Female patients of childbearing age who are not surgically sterilized and male patients whose partners are women of childbearing age must use highly effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of HRS-1167; female patients of childbearing age who are not surgically sterilized must have a negative serum HCG test within 7 days before the first dose, and must be non-lactating;
- Be able to communicate well with the investigators and understand and comply with the requirements in this study.
Key exclusion criteria (17 listed)
- History of or currently suffering from any serious clinical diseases such as diseases in circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases may interfere with the test results
- Any surgery within 6 months before screening, or plan to perform surgery during the study period, or who have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, gastric reduction surgery, etc.);
- Those who donate blood or other reasons of bleeding cause the total loss of blood more than 400mL, or receive blood transfusions, or used blood products within 3 months before screening;
- Allergic constitution, including severe drug allergy or history of drug allergy; Have allergic history to HRS-1167 tablets, rifampicin, rifamycin or their accessories;
- Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 1 year prior to screening; Positive for urine drug abuse screening test;
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-1167 tablets; rifampicinHRS-1167 tablets single oral dose of HRS-1167 or co-administered with rifampicin. | Drug | HRS-1167 with rifampicin |
Primary outcome
Pharmacokinetics parameters of HRS1167: Cmax
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: AUC0-t
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: AUC0-inf
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
5 secondary outcomes
Pharmacokinetics parameters of HRS1167: Tmax
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: t1/2
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: λz
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
Pharmacokinetics parameters of HRS1167: AUC_%Extrap
Time frame: Based on pre-dose, 0-72 hours post-dose sampling times
Incidence and severity of adverse events/serious adverse events (base on CTCAE 5.0)
Time frame: From Day 1 to Day 24 after dose administration
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 28 Feb 2024.
- 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-1167 tablets; rifampicin in people with Advanced Solid Tumor, run by Jiangsu HengRui 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 17 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 28 Feb 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?
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?
Pharmacokinetics parameters of HRS1167: Cmax (time frame: Based on pre-dose, 0-72 hours post-dose sampling times). 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 28 Feb 2024.