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Rheumatoid ArthritisPhase 1NCT05404724

Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects

A Phase 1 study testing itraconazole、 SHR0302 tablets in people with Rheumatoid Arthritis, 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

To evaluate the effect of oral itraconazole on the pharmacokinetics of SHR0302 in healthy subjects. To evaluate the safety and tolerability of oral SHR0302 and itraconazole monotherapy and combination use in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
itraconazole、 SHR0302 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteChina
Study dates
25 Jun 2022to 11 Jul 2022
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Voluntarily sign an informed consent form prior to the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to strictly comply with the clinical trial protocol to complete this trial;
  • Age 18 to 45 years (inclusive, subject to the signing of informed consent), healthy male;
  • Body mass ≥ 50 kg and body mass index (BMI): 19 to 26 kg/m2 (both ends included);
  • Be able to communicate well with the investigators and understand and comply with the requirements of this study.

Who cannot join

  • Those who have participated in clinical trials of any drug and medical device within three months before the first administration or who are still in the follow-up period of a clinical study or 5 half-life periods of the test drug before screening (whichever is longer), the participant in the clinical trial is defined as: those who have signed informed consent for clinical trials and have used the test drugs (including placebo) or experimental medical devices;
  • Those who have chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or gastrointestinal surgery within three years and the researchers believe that there is still clinical significance;
  • Those who have a history of respiratory system, cardiovascular system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities, etc., and the researcher believes that there is still clinical significance;
  • Patients with a history of ventricular dysfunction;
  • Have any history of systemic inflammatory diseases, autoimmune diseases, recurrent herpes zoster, disseminated herpes zoster, and disseminated herpes simplex;
  • Those who have a history of tuberculosis (TB) within half a year before the first administration;
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  • Infections or other acute diseases that need to be treated with antimicrobials (viral, bacterial, fungal, parasitic infections) within 4 weeks before the first administration of the drug are judged by the researchers to be unsuitable for participating in the trial;
  • Allergic to the study drug (SHR0302 tablets and itraconazole capsules) or any ingredient in the study drug, or have a history of allergy to drugs, food or other substances;
  • Those who cannot tolerate intravenous puncture or have a history of blood sickness and needle sickness;
  • Those who have undergone surgery that the researchers judge will affect the absorption, distribution, metabolism and excretion of the drug within 6 months before the first administration; or have undergone surgery within 4 weeks before the first administration; or those who plan to perform surgical operations during the trial period;
  • Those who have used any drugs (including Chinese herbal medicines, health care products, etc.) within 14 days before the first administration, or those who plan to take drugs or health care products that are not experimental in this study during the trial period;
  • Any drug or food that has been used within 30 days prior to the first administration is an inhibitor or inducer of the cytochrome P4503A4 enzyme (CYP3A4), as detailed in Annex 2;
  • those who have received BCG vaccine within 12 months prior to the first dose, or who have been vaccinated or exposed to other live vaccines or live attenuated vaccines within 3 months prior to the first dose, or who plan to be vaccinated during the trial;
  • those who donate blood or lose a large amount of blood (> 400 mL) within 3 months before the first administration, those who receive blood transfusions or use blood products, or those who intend to donate blood or blood components during the trial period or within 3 months after the end of the test;
  • Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the first administration of drugs;
  • Smokers or smokers with more than 5 cigarettes per day in the 3 months before the first administration, or who cannot stop using any tobacco-based products during the trial;
  • Alcoholics or regular drinkers in the 6 months prior to the first administration of the drug, i.e. those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits or 150 mL of wine with an alcohol content of 45 mL); or are unwilling to stop drinking alcohol or any alcoholic products during the trial;
  • those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial period;
  • those who have eaten any beverage or food containing grapefruit within 7 days before the first administration, or any beverage or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc., within 48 hours before the first administration; or do not agree to stop eating the above diet during the trial period;
  • Those who have special requirements for diet and cannot comply with the unified diet;
  • During the test period, strenuous exercise cannot be stopped, or there are other factors that may affect the absorption, distribution, metabolism, excretion and other factors of the drug;
  • Volunteers who have a fertility plan, a sperm donation and egg donation plan during the trial period and 6 months after the end of the trial, or are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, partner sterilization, etc.);
  • Abnormal clinical significance of physical examination, electrocardiogram, vital signs, color ultrasound of the heart and abdomen, chest orthostatic film, and laboratory examination (subject to the judgment of the clinician);
  • ECG examination QTc>440 ms;
  • Glomerular filtration rate (eGFR）<90 mL/min/1.73m2(Adopt simplified renal disease dietary adjustments (MDRDformula calculation,eGFR=186×[serum creatinine value (mg/dL）]-1.154×[Age (years)]-0.203oreGFR=186×[serum creatinine value (μmol/L）×0.01131]-1.154×[Age (years)]-0.203）;
  • Positive uremic screen test;
  • Positive alcohol breath test;
  • Volunteers may not be able to complete this study for other reasons or have other reasons that the researchers judge that they are not suitable to participate in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Third Hospital of Changsha

    Changsha, Hunan, 410000

Other trials in China

About this study

Official title: Study on the Pharmacokinetic Effects of Single-centered, Open, Single-arm, Fixed-sequence Itraconazole on SHR0302 Tablets in Healthy Subjects

To evaluate the effect of oral itraconazole on the pharmacokinetics of SHR0302 in healthy subjects.

To evaluate the safety and tolerability of oral SHR0302 and itraconazole monotherapy and combination use in healthy subjects.

Being tested
itraconazole、 SHR0302 tablets
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • itraconazole、 SHR0302 tabletsDrug

    Itraconazole 7 times and SHR0302 tablets twice. On the 8th day of this, itraconazole and SHR0302 tablets were taken simultaneously.

Study groups in NCT05404724
Study groupRoleWhat they receive
Treatment groupExperimentalitraconazole and SHR0302 tablets
Receives: Drug: itraconazole、 SHR0302 tablets

What is being measured

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

  1. SHR0302 and its main metabolite AUC0-t

    Measured: day 1 to day 11

  2. SHR0302 and its main metabolite AUC0-inf

    Measured: day 1 to day 11

  3. SHR0302 and its main metabolite Cmax

    Measured: day 1 to day 11

Secondary outcomes (5)

  1. SHR0302 and its main metabolite Tmax (SHR0302 only)

    Measured: day 1 to day 11

  2. SHR0302 and its main metabolite t1/2 (SHR0302 only)

    Measured: day 1 to day 11

  3. SHR0302 and its main metabolite CL/F (SHR0302 only)

    Measured: day 1 to day 11

  4. SHR0302 and its main metabolite Vz/F (SHR0302 only)

    Measured: day 1 to day 11

  5. Adverse events

    Measured: 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.

  1. First posted3 Jun 2022
  2. Study start25 Jun 2022
  3. Primary completion11 Jul 2022
  4. Study completion11 Jul 2022

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
itraconazole and SHR0302 tablets are used in combination
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05404724
Sponsor's protocol ID
SHR0302-110
Status last verified
Dec 2022
First submitted
31 May 2022
Last updated
22 Dec 2022
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 itraconazole、 SHR0302 tablets in people with Rheumatoid Arthritis, 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 28 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 22 Dec 2022. 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?

SHR0302 and its main metabolite AUC0-t (time frame: 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?

On the ClinicalTrials.gov record for NCT05404724.

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 22 Dec 2022.

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