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B-cell TumorsPhase 1NCT05560360

A Trial of DDI Between SHR1459 and Efavirenz With Healthy Subjects

A Phase 1 study testing SHR1459 tablet and Efavirenz tablet in people with B-cell Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study used a single-dose, open and fixed sequence design to compare the pharmacokinetics 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
B-cell Tumors
What is being tested?
SHR1459 tablet and Efavirenz tablet
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
4 Nov 2022to 27 Jan 2023
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

  • Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions;
  • Age 18-45 (including threshold), male and female(at least 5 female subjects);
  • Weight ≥ 50 kg for male, weight ≥ 45 kg for female, body mass index (BMI): 18.5~30 kg/m2 (including critical value);
  • Heart rate 60-100 bpm;
  • Be able to communicate well with the investigators and understand and comply with the requirements in this study.

Who cannot join

  • Physical examination, vital signs, blood-routine examination, blood biochemistry, infectious disease screening, coagulation function, urine-routine examination, chest x-ray, B ultrasound and other examination results are abnormal and judged by the research doctor as clinically significant;
  • Glomerular filtration rate (GFR) < 90 mL/min/1.73 m2;
  • 12-lead ECG abnormalities, in which QTcF≥ 430 ms for men and QTcF≥ 450 ms for women, (the QTc interval is corrected by the Fridericia formula (QTcF = QT/(RR^0.33), RR is the standardized heart rate value, divided by heart rate of 60), sinus arrhythmias, sinus bradycardia, or other abnormalities are judged to be clinically significant by research physicians;
  • Those who have previously suffered from severe heart, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, neurological or psychiatric diseases or existing above diseases, which are judged by the research doctor to be unfit for participants;
  • Those who have undergone any surgery within 6 months prior to screening; or have previously undergone any surgery that affects the absorption of the drug in the stomach and intestines (including gastrectomy, bowel resection, gastric contraction surgery, etc.) and any surgery that affects liver function (including cholecystectomy, etc.);
  • Screening for any acute illness that has occurred within the month prior to the study as clinically significant;
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  • Those with a specific history of allergies (e.g., asthma, urticaria, eczema, etc.), or have allergic constitution (those who are allergic to two or more drugs, foods, or environmental substances such as alcohol, milk, pollen, etc.), or those with a known history of allergies to SHR1459, efavirenz, or their excipients (SHR1459, see Appendix 2 for efavirenz excipients);
  • Have used any drugs that effect enzyme activity (e.g., antivirals, antifungals, antiplatelet aggregations, etc.) in the month prior to taking the study drug;
  • Have any prescription drugs, nonprescription drugs, vitamins, health supplements, proprietary Chinese medicines and herbs within month before taking the research drugs;
  • Persons with history of drug abuse/dependence in the past five years; Those with history of drug abuse or positive drug screening (including morphine, methamphetamine( methamphetamine), ketamine, ecstasy (methylenedioxyamphetamine), cocaine, cannabis (tetrahydrocannabinol acid) positive);
  • Alcohol abuse in the 3 months prior to screening, with an average daily intake of more than 15g of alcohol (equivalent to 145 mL of wine, 450 mL of beer or 43 mL of liquor with an alcohol content of 40%), and those who cannot abstain from alcohol during the trial, or those who have a positive alcohol breath screening;
  • 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;
  • Those who donate blood or other reasons of bleeding cause the total loss of blood more than 200mL or receive blood transfusions within 3 months before screening;
  • Those who have used other experimental drugs or medical devices within 3 months before screening or who have used experimental biological macromolecules within 1 year;
  • 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 (animal liver, etc.), or grapefruit, star fruit and other fruits or juices that may affect metabolism;
  • Can not comply with the unified dietary arrangement or have special requirements for diet (such as intolerance to standard meal food, etc.); Or those who have strenuous exercise or are unwilling to accept the lifestyle required by the program; Or have other factors that affect the absorption, distribution, metabolism, excretion and other factors of the drug;
  • Those who have been vaccinated against the COVID-19 within one month before the first administration, or those who have received other vaccinations in the previous 3 months of screening;
  • Who have blood phobia and faint with acupuncture ; or those with poor vascular conditions, inability to embed needles or inability to tolerate venipuncture;
  • Lactating women, or female subjects who used long-acting estrogen or progestin injections (containing progestin-type intrauterine devices) or implant within 6 months prior to screening;
  • Women of childbearing potential (WOCBP) who have a positive serum pregnancy test;
  • Screening of persons who have had unprotected sex with their partners/sexual partners within one month prior to the screening;
  • Women of childbearing potential and sexual partners who have a WOCBP have a pregnancy plan or sperm donation, ovum donation program, or do not use medically approved contraception from the beginning of signing the informed consent form to 12 weeks after the last drug use;
  • 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 First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222002

Other trials in China

About this study

Official title: Study of the Pharmacokinetic Effects of Efavirenz on the Pharmacokinetics of SHR1459 in Healthy Subjects

This study used a single-dose, open and fixed sequence design to compare the pharmacokinetics in healthy subjects.

Conditions
B-cell Tumors
Being tested
SHR1459 tablet, Efavirenz tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR1459 tabletDrug

    100 mg/tablet; administered orally

  • Efavirenz tabletDrug

    600 mg/tablet; administered orally

Study groups in NCT05560360
Study groupRoleWhat they receive
healthy subjectsExperimentalNot described
Receives: Drug: SHR1459 tablet; Drug: Efavirenz tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics parameters of SHR1459: Cmax

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

  2. Pharmacokinetics parameters of SHR1459: AUC0-t

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

  3. Pharmacokinetics parameters of SHR1459: AUC0-inf

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

Secondary outcomes (5)

  1. Pharmacokinetics parameters of SHR1459: Tmax

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

  2. Pharmacokinetics parameters of SHR1459: T1/2

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

  3. Pharmacokinetics parameters of SHR1459: CL/F

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

  4. Pharmacokinetics parameters of SHR1459: Vz/F

    Measured: Based on pre-dose, 0-24 hours post-dose sampling times

  5. Incidence and severity of adverse events/serious adverse events (base on CTC AE 5.0)

    Measured: Based on pre-dose to Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start4 Nov 2022
  3. Primary completion2 Dec 2022
  4. Study completion27 Jan 2023

Resources

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 efavirenz on SHR1459 in healthy subjects.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560360
Sponsor's protocol ID
SHR1459-I-110
Status last verified
Feb 2023
First submitted
27 Sep 2022
Last updated
2 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR1459 tablet and Efavirenz tablet in people with B-cell Tumors, 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 5 inclusion and 23 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 2 Feb 2023. 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 SHR1459: Cmax (time frame: Based on pre-dose, 0-24 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?

On the ClinicalTrials.gov record for NCT05560360.

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 2 Feb 2023.

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