Healthy Adult SubjectsPhase 1NCT04627129
A Itraconazole Effect Study of SHR2554 on Healthy Chinese Adult Subjects
A Phase 1 study testing SHR2554 and Itraconazole in people with Healthy Adult Subjects, 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 Itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally 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
- Healthy Adult Subjects
- What is being tested?
- SHR2554 and Itraconazole
- 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
- 1 Jun 2020to 1 Oct 2020
- 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
- Subjects must meet all of the following criteria to enter the study:
- The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood;
- Be able to complete the study according to the requirements of the test scheme;
- Healthy male and female subjects aged 18 to 45 years (including both ends) on the date of signing informed consent;
- The subjects have a childbearing plan and are unwilling to take effective contraceptive measures 2 weeks before the study administration (only female subjects) and 3 months after the last administration of the drug; those who are fertile and whose serum hCG test is not negative before the study medication;
- The body weight of male subjects is no less than 50 kg and that of female subjects is no less than 45 kg. Body mass index (BMI) is in the range of 19.0-26.0 kg/m2 (including the critical value).
Who cannot join
- Allergic constitution, including severe drug allergy or drug allergy history; allergic history of SHR2554 tablets, Iitraconazole or their excipients;
- People who have a history of drug and/or alcohol abuse, have a positive alcohol or drug screening test, or have a history of drug abuse in the past five years or have used drugs within 3 months before the test;
- Smoking and alcohol addicts within 3 months before the tes (drinking 14 units of alcohol per week: 1 unit = 360 ml beer,45 ml spirits, or 150 ml wine; smoking ≥ 5 cigarettes a day) and unable to prohibit smoking and alcohol during the test period;
- A clear medical history of primary diseases of important organs such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system, etc., the investigator considers not suitable for participating in this study;
- Those who have undergone any surgery within 6 months before screening;
- Hepatotoxic drugs (such as Dapsone, Erythromycin, Fluconazole, Ketoconazole, Rifampin) have been taken for a long period of time in the 6 months before screening;
Show all 17Show fewer
- Those who have taken any clinical trial drugs within 3 months;
- Any drug that changes liver enzyme activity was taken within 28 days before taking the study drug;
- Any prescription or over-the-counter drugs、vitamin products, health products or Chinese herbal medicine taken within 14 days before taking the study drug;
- Ingested grapefruit or products containing grapefruit, food or drink containing caffeine, xanthine or alcohol within 48 hours before taking the study drug; strenuous exercise, or other factors that affect the absorption, distribution, metabolism, and excretion of the study drug;
- Patients with abnormal vital signs (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; heart rate < 50 BPM or > 100 BPM) or physical examination, electrocardiogram, laboratory examination and other abnormalities have clinical significance (subject to the judgment of clinicians);
- Color Doppler echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50% or QT interval corrected by friderica method in 12 lead ECG was ≥ 480msec in female subjects and ≥ 450msec in male subjects;
- HCV antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive;
- Participated in blood donation within 3 months before taking the study drug and donate blood ≥200 mL, or received blood transfusion;
- People with a history of fainting needles and blood, have difficulty in blood collection or cannot tolerate venipuncture blood collection;
- Women during pregnancy and lactation;
- Subjects with other factors not suitable to participate in this study as considered by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open, Single Does, Drug-drug Interaction Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of SHR2554 Tablets
The primary objective of the study is to evaluate the effect of Itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
Read the detailed description
SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12
- Conditions
- Healthy Adult Subjects
- Being tested
- SHR2554 and Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554 and ItraconazoleDrug
Single dose of oral administration of SHR2554 and Multiple dose of oral of Itraconazole Capsules
| Study group | Role | What they receive |
|---|---|---|
| SHR2554+Itraconazole | Experimental | SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12 Receives: Drug: SHR2554 and Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics parameter of SHR2554
Measured: Day 1 and Day 11
AUC0-t
Pharmacokinetics parameter of SHR2554
Measured: Day 1 and Day 11
AUC0-∞
Pharmacokinetics parameter of SHR2554: AUC0-∞
Measured: Day 1 and Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jun 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- 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
- NCT04627129
- Sponsor's protocol ID
- SHR2554-I-106
- Status last verified
- Nov 2020
- First submitted
- 27 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Single Does, Drug-drug Interaction Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of SHR2554 Tablets
- ClinicalTrials.gov ID
- NCT04627129
- Acronym / sponsor ID
- SHR2554-I-106
- Conditions
- Healthy Adult Subjects
- 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
- 1 Jun 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 13 Nov 2020 (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 Itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
Detailed description
SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR2554+Itraconazole | Experimental | Drug: SHR2554 and ItraconazoleSHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood;
- Be able to complete the study according to the requirements of the test scheme;
- Healthy male and female subjects aged 18 to 45 years (including both ends) on the date of signing informed consent;
- The subjects have a childbearing plan and are unwilling to take effective contraceptive measures 2 weeks before the study administration (only female subjects) and 3 months after the last administration of the drug; those who are fertile and whose serum hCG test is not negative before the study medication;
- The body weight of male subjects is no less than 50 kg and that of female subjects is no less than 45 kg. Body mass index (BMI) is in the range of 19.0-26.0 kg/m2 (including the critical value).
Key exclusion criteria (17 listed)
- Allergic constitution, including severe drug allergy or drug allergy history; allergic history of SHR2554 tablets, Iitraconazole or their excipients;
- People who have a history of drug and/or alcohol abuse, have a positive alcohol or drug screening test, or have a history of drug abuse in the past five years or have used drugs within 3 months before the test;
- Smoking and alcohol addicts within 3 months before the tes (drinking 14 units of alcohol per week: 1 unit = 360 ml beer,45 ml spirits, or 150 ml wine; smoking ≥ 5 cigarettes a day) and unable to prohibit smoking and alcohol during the test period;
- A clear medical history of primary diseases of important organs such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system, etc., the investigator considers not suitable for participating in this study;
- Those who have undergone any surgery within 6 months before 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 |
|---|---|---|
| SHR2554 and ItraconazoleSingle dose of oral administration of SHR2554 and Multiple dose of oral of Itraconazole Capsules | Drug | SHR2554+Itraconazole |
Primary outcome
Cmax
Time frame: Day 1 and Day 11
Pharmacokinetics parameter of SHR2554
AUC0-t
Time frame: Day 1 and Day 11
Pharmacokinetics parameter of SHR2554
AUC0-∞
Time frame: Day 1 and Day 11
Pharmacokinetics parameter of SHR2554: AUC0-∞
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 13 Nov 2020.
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Healthy Subjects
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 SHR2554 and Itraconazole in people with Healthy Adult Subjects, 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 6 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 13 Nov 2020. 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?
Cmax (time frame: Day 1 and 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?
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 13 Nov 2020.