Advanced Solid TumorPhase 1NCT04973020
A Drug-drug Interaction Study of SHR6390 on Healthy Chinese Volunteers
A Phase 1 study testing SHR6390、efavirenz in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22 , and from Day8 to Day26 take the efavirenz. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SHR6390、efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 28 Oct 2021
- 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
- The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
- Healthy subjects aged 18~45 (including 18 and 45 years old);
- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
- The subjects had no fertility plan, took effective contraceptive measures voluntarily, and could not donate sperm or eggs within 7 months after signing the informed consent form to the last medication; the serum HCG test of women with fertility must be negative before the study medication.
Who cannot join
- Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
- Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
- Those who donated blood or suffered heavy blood loss (≥400 mL), received blood transfusions, or used blood products within 3 months before enrollment;
- Have a history of allergies to drugs, food or other substances;
- Those who have used soft drugs (such as marijuana) within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; Those with positive results in urine drug abuse screening;
- Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
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- Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements), especially the drugs which have any effect on CYP3A4;
- Regular drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), and any alcohol-containing products cannot be stopped during the study Those who are positive for alcohol breath test;
- Those with any abnormal result (clinically significant) of vital signs, physical examination, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, colour Doppler echocardiography, hematology, clinical chemistry, urinalysis and coagulation;
- Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital Beijing, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: A Single-centre, Single-dose, Open-label and Self-control Study to Evaluate the Effect of Efavirenz on Pharmacokinetic of SHR6390 in Healthy Chinese Subjects
The study is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22 , and from Day8 to Day26 take the efavirenz.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR6390、efavirenz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390、efavirenzDrug
SHR6390 tablet single dose；Efavirenz single dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: SHR6390、efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose.
Measured: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Cmax
Maximum observed serum concentration (Cmax)for SHR6390 after Single dose.
Measured: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
AUC0-t
Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose.
Measured: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
AUC0-inf
Area under the plasma concentration versus time curve (AUC0-inf ) for SHR6390 after Single dose.
Measured: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
T1/2
Time to elimination half-life (T1/2) for for SHR6390 after Single dose.
Measured: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Secondary outcomes (1)
Number of subjects with adverse events and severity of adverse events
Measured: from Day 1 to Day 34 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Sep 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a single-center, open, single-dose, self-controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04973020
- Sponsor's protocol ID
- SHR6390-I-111
- Status last verified
- Nov 2021
- First submitted
- 11 Jul 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang J, Hu C, Zhang L. Effect of Efavirenz on the Pharmacokinetics of SHR6390 in Healthy Volunteers. Drug Des Devel Ther. 2024 Jul 19;18:3113-3119. doi: 10.2147/DDDT.S468478. eCollection 2024.
PubMed 39050802
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Single-dose, Open-label and Self-control Study to Evaluate the Effect of Efavirenz on Pharmacokinetic of SHR6390 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04973020
- Acronym / sponsor ID
- SHR6390-I-111
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 22 Jul 2021 (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 is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22 , and from Day8 to Day26 take the efavirenz.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a single-center, open, single-dose, self-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR6390、efavirenz |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
- Healthy subjects aged 18~45 (including 18 and 45 years old);
- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
- The subjects had no fertility plan, took effective contraceptive measures voluntarily, and could not donate sperm or eggs within 7 months after signing the informed consent form to the last medication; the serum HCG test of women with fertility must be negative before the study medication.
Key exclusion criteria (10 listed)
- Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
- Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
- Those who donated blood or suffered heavy blood loss (≥400 mL), received blood transfusions, or used blood products within 3 months before enrollment;
- Have a history of allergies to drugs, food or other substances;
- Those who have used soft drugs (such as marijuana) within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; Those with positive results in urine drug abuse screening;
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 |
|---|---|---|
| SHR6390、efavirenzSHR6390 tablet single dose；Efavirenz single dose. | Drug | Treatment group |
Primary outcome
Tmax
Time frame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose.
Cmax
Time frame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Maximum observed serum concentration (Cmax)for SHR6390 after Single dose.
AUC0-t
Time frame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose.
AUC0-inf
Time frame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Area under the plasma concentration versus time curve (AUC0-inf ) for SHR6390 after Single dose.
T1/2
Time frame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Time to elimination half-life (T1/2) for for SHR6390 after Single dose.
1 secondary outcome
Number of subjects with adverse events and severity of adverse events
Time frame: from Day 1 to Day 34 after the first dose
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 29 Nov 2021.
- Derived from this study: PubMed 39050802Wang J, Hu C, Zhang L. Effect of Efavirenz on the Pharmacokinetics of SHR6390 in Healthy Volunteers. Drug Des Devel Ther. 2024 Jul 19;18:3113-3119. doi: 10.2147/DDDT.S468478. eCollection 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 SHR6390、efavirenz 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 10 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 29 Nov 2021. 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?
Tmax (time frame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second 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?
On the ClinicalTrials.gov record for NCT04973020, which also lists 1 linked publication.
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 29 Nov 2021.