Healthy SubjectsPhase 1NCT04479891
Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects
A Phase 1 study testing pyrotinib tablet and Itraconazole capsule in people with Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- pyrotinib tablet and Itraconazole capsule
- 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
- 18 Sep 2019to 30 Nov 2019
- 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
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Able to complete the study as required by the protocol;
- Subjects have no birth plan and voluntarily take effective contraception from 2 weeks before administration to 3 months after the last dose, and the pre-drug serum HCG test for fertility-enabled women must be negative;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m2 ;
- No clinically significant abnormalities in general physical examination, vital signs, laboratory tests, etc.
Who cannot join
- Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
- Allergic constitution or known allergy to pyrotinib, itraconazole or the excipients;
- History of drug abuse in the past 5 years, or positive for drug abuse screening;
- Alcoholic or often drinkers with drinking amount more than 14 units a week; a heavy smoker; and can't abstain from smoking and alcohol during the study
- Left ventricular ejection fraction (LVEF) <50% by echocardiography or QTcF ≥ 470 msec by 12 lead electrocardiograph;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system that are not suitable for subjects to participate in the study, as judged by the investigator;
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- Any surgery within 6 months before screening;
- Have taken hepatotoxic drugs for a long time within 6 months before screening;
- Subjects who took any clinical trial drugs within 3 months;
- Subjects who took any drugs that change liver enzymes activity within 28 days before dosing; or took any prescription drugs, over-the-counter drugs or vitamins, health products or herbal medicine within 14 days before dosing;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
- Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing; strenuous exercise; or other factors which affect drug absorption, distribution, metabolism, excretion, etc.;
- Other factors that are not suitable for subjects to participate in the study, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects
The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.
- Conditions
- Healthy Subjects
- Being tested
- pyrotinib tablet, Itraconazole capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinib tabletDrug
single oral dose of SHR6390 or co-administered with itraconazole
Itraconazole capsuleDrug
200 mg itraconazole QD
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib alone, pyrotinib + itraconazole | Experimental | Sequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between. Receives: Drug: pyrotinib tablet; Drug: Itraconazole capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of pyrotinib
Maximum concentration (Cmax) of pyrotinib
Measured: Day 1 and Day 9
AUC of pyrotinib
Area under the plasma concentration versus time curve of SHR6390
Measured: Day 1 and Day 9
Secondary outcomes (3)
Tmax of pyrotinib
Time of maximum concentration of pyrotinib
Measured: Day 1 and Day 9
T1/2 of pyrotinib
Terminal half-life of pyrotinib
Measured: Day 1 and Day 9
AEs and SAEs
Adverse events and serious adverse events
Measured: From the first drug administration to 7 days after the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start18 Sep 2019
- Primary completion11 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Model description
- Pyrotinib alone and then combined with itraconazole
- 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
- NCT04479891
- Sponsor's protocol ID
- HR-BLTN-DDI-01
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 21 Jul 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04479891
- Acronym / sponsor ID
- HR-BLTN-DDI-01
- Conditions
- Healthy 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
- 18 Sep 2019 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 21 Jul 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 study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pyrotinib alone and then combined with itraconazole
| Arm | Type | Receives |
|---|---|---|
| pyrotinib alone, pyrotinib + itraconazole | Experimental | Drug: pyrotinib tablet, Drug: Itraconazole capsuleSequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Able to complete the study as required by the protocol;
- Subjects have no birth plan and voluntarily take effective contraception from 2 weeks before administration to 3 months after the last dose, and the pre-drug serum HCG test for fertility-enabled women must be negative;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m2 ;
- No clinically significant abnormalities in general physical examination, vital signs, laboratory tests, etc.
Key exclusion criteria (13 listed)
- Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
- Allergic constitution or known allergy to pyrotinib, itraconazole or the excipients;
- History of drug abuse in the past 5 years, or positive for drug abuse screening;
- Alcoholic or often drinkers with drinking amount more than 14 units a week; a heavy smoker; and can't abstain from smoking and alcohol during the study
- Left ventricular ejection fraction (LVEF) <50% by echocardiography or QTcF ≥ 470 msec by 12 lead electrocardiograph;
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 |
|---|---|---|
| pyrotinib tabletsingle oral dose of SHR6390 or co-administered with itraconazole | Drug | pyrotinib alone, pyrotinib + itraconazole |
| Itraconazole capsule200 mg itraconazole QD | Drug | pyrotinib alone, pyrotinib + itraconazole |
Primary outcome
Cmax of pyrotinib
Time frame: Day 1 and Day 9
Maximum concentration (Cmax) of pyrotinib
AUC of pyrotinib
Time frame: Day 1 and Day 9
Area under the plasma concentration versus time curve of SHR6390
3 secondary outcomes
Tmax of pyrotinib
Time frame: Day 1 and Day 9
T1/2 of pyrotinib
Time frame: Day 1 and Day 9
AEs and SAEs
Time frame: From the first drug administration to 7 days after the last drug 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 21 Jul 2020.
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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 pyrotinib tablet and Itraconazole capsule in people with Healthy 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 5 inclusion and 13 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 21 Jul 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 of pyrotinib (time frame: Day 1 and Day 9). The study lists 2 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 21 Jul 2020.