Healthy ParticipantsPhase 1NCT04315493
Effect of Low-fat Diet on the Pharmacokinetics of Pyrotinib in Healthy Participants
A Phase 1 study testing pyrotinib maleate fasted in P1, low-fat diet in P2 and pyrotinib maleate low-fat diet in P1, fasted in P2 in people with Healthy Participants, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets. The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- pyrotinib maleate fasted in P1, low-fat diet in P2 and pyrotinib maleate low-fat diet in P1, fasted in P2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Apr 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
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Have no fertility plan and agree to adopt effective contraceptive measures within 2 weeks before the first study drug administration and up to 3 months after the last study drug administration. Negative pregnancy test for women of child-bearing age before the first study drug administration;
- Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m^2 (including 19 and 26);
- During screening period, the comprehensive physical examination (vital signs and physical examination), routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation,etc), 12-lead electrocardiogram (ECG), chest X-ray, cardiac ultrasound, B ultrasound and other examination results must be within the normal range, or judged to be "no clinical significance (NCS)" if beyond the normal range;
Who cannot join
- Blood donation within 3 months before the first drug administration and blood loss greater than 400 mL, or receiving blood transfusion;
- Allergic constitution, including those with severe drug allergies or a history of drug allergies, or known allergy to the research drug;
- History of drug use, or drug abuse screening positive; history of drug abuse within the past five years or have used drugs 3 months before the test;
- Alcoholic or often drinkers (the average drinking amount is more than 14 units a week: 1 unit= 285 ml beer or 45 ml spirits or 100 ml wine; ≥5 cigarettes per day) and can't quit smoking and alcohol during the study; alcohol test positive;
- The 12-lead ECG with female QTcF > 470ms or male QTcF > 450ms;
- Left ventricular ejection fraction (LVEF) <50% by echocardiography;
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- 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.
- Those who have undergone any surgery within 6 months before screening;
- Those who have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for a long time within the 6 months before screening;
- Those who have taken any research drugs within 3 months before the first drug administration;
- Use any drugs that changes liver enzyme activity within 4 weeks before the first drug administration;
- Use any prescription or over-the-counter drug, any vitamin product, health supplement or herbal medicine within 2 weeks prior to first drug administration;
- Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases;
- HCV antibody positive, HIV antibody positive, HBsAg positive, and syphilis antibody positive;
- Consumption of grapefruit or grapefruit-containing products, foods or beverages containing caffeine, xanthine, or alcohol within 48 hours before the first drug administration; strenuous exercise or other factors that effect on drug absorption, distribution, metabolism and excretion;
- Have special requirements on diet and cannot comply with the diet and corresponding regulations provided by the test;
- History of dizzy needles or blood dizziness; difficulty in venous blood collection or inability to tolerate venipuncture;
- lactating women;
- Other factors that are not suitable for participating in the study, as judged by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open, Single-dose, Two-cycle, Double-sequence, Crossover Study to Investigate the Effects of a Low-fat Diet On the Pharmacokinetics of Healthy Chinese Adult Participants After Oral Administration of Pyrotinib Maleate Tablets
The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets.
The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- pyrotinib maleate fasted in P1, low-fat diet in P2, pyrotinib maleate low-fat diet in P1, fasted in P2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinib maleate fasted in P1, low-fat diet in P2Drug
pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2
pyrotinib maleate low-fat diet in P1, fasted in P2Drug
pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: pyrotinib maleate fasted in P1, low-fat diet in P2 |
| B | Experimental | Not described Receives: Drug: pyrotinib maleate low-fat diet in P1, fasted in P2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter: Cmax of pyrotinib
Peak Plasma Concentration (Cmax) of pyrotinib
Measured: through study completion, an average of 28 days
Pharmacokinetics parameter: AUC of pyrotinib
Area under the plasma concentration versus time curve (AUC) of pyrotinib
Measured: through study completion, an average of 28 days
Secondary outcomes (5)
Pharmacokinetics parameter: Tmax of pyrotinib
Time of maximum observed concentration (Tmax) of pyrotinib
Measured: through study completion, an average of 28 days
Pharmacokinetics parameter: T1/2 of pyrotinib
Half time (T1/2) of pyrotinib
Measured: through study completion, an average of 28 days
Pharmacokinetics parameter: CL/F of pyrotinib
Total body clearance for extravascular administration (CL/F) of pyrotinib
Measured: through study completion, an average of 28 days
Pharmacokinetics parameter: Vz/F of pyrotinib
Volume of distribution (Vz/F) of pyrotinib
Measured: through study completion, an average of 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a patient or clinical study participant
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
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
- NCT04315493
- Sponsor's protocol ID
- BLTN-If
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Single-dose, Two-cycle, Double-sequence, Crossover Study to Investigate the Effects of a Low-fat Diet On the Pharmacokinetics of Healthy Chinese Adult Participants After Oral Administration of Pyrotinib Maleate Tablets
- ClinicalTrials.gov ID
- NCT04315493
- Acronym / sponsor ID
- BLTN-If
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 19 Mar 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 low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets.
The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: pyrotinib maleate fasted in P1, low-fat diet in P2 |
| B | Experimental | Drug: pyrotinib maleate low-fat diet in P1, fasted in P2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Have no fertility plan and agree to adopt effective contraceptive measures within 2 weeks before the first study drug administration and up to 3 months after the last study drug administration. Negative pregnancy test for women of child-bearing age before the first study drug administration;
- Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m^2 (including 19 and 26);
Key exclusion criteria (19 listed)
- Blood donation within 3 months before the first drug administration and blood loss greater than 400 mL, or receiving blood transfusion;
- Allergic constitution, including those with severe drug allergies or a history of drug allergies, or known allergy to the research drug;
- History of drug use, or drug abuse screening positive; history of drug abuse within the past five years or have used drugs 3 months before the test;
- Alcoholic or often drinkers (the average drinking amount is more than 14 units a week: 1 unit= 285 ml beer or 45 ml spirits or 100 ml wine; ≥5 cigarettes per day) and can't quit smoking and alcohol during the study; alcohol test positive;
- The 12-lead ECG with female QTcF > 470ms or male QTcF > 450ms;
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 maleate fasted in P1, low-fat diet in P2pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2 | Drug | A |
| pyrotinib maleate low-fat diet in P1, fasted in P2pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2 | Drug | B |
Primary outcome
Pharmacokinetics parameter: Cmax of pyrotinib
Time frame: through study completion, an average of 28 days
Peak Plasma Concentration (Cmax) of pyrotinib
Pharmacokinetics parameter: AUC of pyrotinib
Time frame: through study completion, an average of 28 days
Area under the plasma concentration versus time curve (AUC) of pyrotinib
5 secondary outcomes
Pharmacokinetics parameter: Tmax of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: T1/2 of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: CL/F of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: Vz/F of pyrotinib
Time frame: through study completion, an average of 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pyrotinib maleate fasted in P1, low-fat diet in P2 and pyrotinib maleate low-fat diet in P1, fasted in P2 in people with Healthy Participants, run by Jiangsu HengRui Medicine Co., Ltd..
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 19 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuya Wang, Ph.D. (86-13918749176, wangyuya@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameter: Cmax of pyrotinib (time frame: through study completion, an average of 28 days). 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 19 Mar 2020.