HER2-positive Recurrent / Metastatic Breast CancerPhase 1NCT05252546
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
A Phase 1 study testing pyrotinib tablet, Montmorillonite Power and Loperamide in people with HER2-positive Recurrent / Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with each drug 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
- HER2-positive Recurrent / Metastatic Breast Cancer
- What is being tested?
- pyrotinib tablet, Montmorillonite Power and Loperamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2022to 2 Aug 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
- 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.
- Healthy male and female subjects aged 18 to 45 years on the day of signing the informed consent form; appropriate proportion of subjects of different genders (no less than 3 of single gender) required in both groups A and B.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m2.
- Subjects of childbearing potential and their partners have no birth plan and voluntarily take effective contraception during the course of clinical trial until 3 months after the last dose (Female subjects are also required to use highly effective non-drug contraception starting two weeks before study entry and can use contraceptives after study completion).
Who cannot join
- Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound or known allergy to pyrotinib, montmorillonite power, loperamide or the excipients;
- History of drug abuse in the past 5 years, or positive for drug abuse screening;
- History of alcoholism with alcohol consumption over 14 units per week; heavy smoker; and can't abstain from smoking and alcohol during the study
- QTcF >470 msec for females or >450 msec for males by 12 lead electrocardiograph;
- Left ventricular ejection fraction (LVEF) <50% by echocardiography
Show all 21Show fewer
- Significant history or clinical manifestation of any neurological, cardiovascular, renal, gastrointestinal, pulmonary, respiratory, metabolic and musculoskeletal disorder, as determined by the Investigator (or designee).
- Any surgery within 6 months before screening;
- Intake of hepatotoxic drugs for a long time within 6 months before screening;
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months;
- Subjects who took any drugs that change liver enzymes activity within 28 days before dosing;
- Subjects who took any prescription drugs, over-the-counter drugs or vitamins, health products or herbal medicine within 14 days before dosing;
- Clinically significant abnormalities as determined by the Investigator (or designee) in general physical examination, vital signs, laboratory tests, etc.
- Pregnant or lactating females
- Positive serology test results for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or human immunodeficiency virus antibody.
- 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
- Subjects who need to avoid inhibiting intestinal peristalsis, such as patients with flatulence or constipation, or gastrointestinal symptoms such as diarrhea, dry mouth, abdominal distension, anorexia, gastrointestinal spasm, nausea, vomiting, as well as dizziness, headache and fatigue;
- Those who have special requirements for diet and cannot comply with the diet and corresponding requirements provided by the trial;
- Those who cannot tolerate venipuncture or with a history of needle-sickness and blood-sickness.
- Those who have received a live vaccine 2 weeks prior to dosing or are scheduled to be vaccinated within 7 days after study completion.
- Subjects who, in the opinion of the Investigator should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open, Single-dose, Fixed-sequence Study to Investigate the Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with each drug will also be assessed.
- Being tested
- pyrotinib tablet, Montmorillonite Power, Loperamide
- Medical subject headings
- Breast Neoplasms
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 pyrotinib or co-administered with Montmorillonite Power or Loperamide
Montmorillonite PowerDrug
3 g or one pouch of montmorillonite power 2 hours after pyrotinib administration
LoperamideDrug
4 mg of loperamide with pyrotinib followed by 2mg every 2 hours for 2 times for a total of 8mg/day
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib alone, then pyrotinib + Montmorillonite Power or Loperamide | Experimental | Sequential treatments of pyrotinib alone followed by pyrotinib + Montmorillonite Power or Loperamide, with a washout period in between. Receives: Drug: pyrotinib tablet; Drug: Montmorillonite Power; Drug: Loperamide |
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 pyrotinib
Measured: Day 1 and Day 9
Secondary outcomes (4)
PK parameters （Tmax） 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
PK parameters （CL/F） of pyrotinib
Measured: Day 1 and Day 9
PK parameters （Vz/F） of pyrotinib
Measured: Day 1 and Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start8 Mar 2022
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive Recurrent / Metastatic Breast CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pyrotinib alone and then combined with Montmorillonite Power or Loperamide
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05252546
- Sponsor's protocol ID
- HR-BLTN-DDI-07
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Li D, Zhang T, Xu S, Zhang Y, Zhao K, Li S, Shen K, Li X, Xu P. Evaluation of the pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib in healthy volunteers. Front Pharmacol. 2025 May 12;16:1563556. doi: 10.3389/fphar.2025.1563556. eCollection 2025.
PubMed 40433999
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open, Single-dose, Fixed-sequence Study to Investigate the Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT05252546
- Acronym / sponsor ID
- HR-BLTN-DDI-07
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 23 Feb 2022 (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 anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with each drug will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pyrotinib alone and then combined with Montmorillonite Power or Loperamide
| Arm | Type | Receives |
|---|---|---|
| pyrotinib alone, then pyrotinib + Montmorillonite Power or Loperamide | Experimental | Drug: pyrotinib tablet, Drug: Montmorillonite Power, Drug: LoperamideSequential treatments of pyrotinib alone followed by pyrotinib + Montmorillonite Power or Loperamide, 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.
- Healthy male and female subjects aged 18 to 45 years on the day of signing the informed consent form; appropriate proportion of subjects of different genders (no less than 3 of single gender) required in both groups A and B.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m2.
- Subjects of childbearing potential and their partners have no birth plan and voluntarily take effective contraception during the course of clinical trial until 3 months after the last dose (Female subjects are also required to use highly effective non-drug contraception starting two weeks before study entry and can use contraceptives after study completion).
Key exclusion criteria (21 listed)
- Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound or known allergy to pyrotinib, montmorillonite power, loperamide or the excipients;
- History of drug abuse in the past 5 years, or positive for drug abuse screening;
- History of alcoholism with alcohol consumption over 14 units per week; heavy smoker; and can't abstain from smoking and alcohol during the study
- QTcF >470 msec for females or >450 msec for males 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 pyrotinib or co-administered with Montmorillonite Power or Loperamide | Drug | pyrotinib alone, then pyrotinib + Montmorillonite Power or Loperamide |
| Montmorillonite Power3 g or one pouch of montmorillonite power 2 hours after pyrotinib administration | Drug | pyrotinib alone, then pyrotinib + Montmorillonite Power or Loperamide |
| Loperamide4 mg of loperamide with pyrotinib followed by 2mg every 2 hours for 2 times for a total of 8mg/day | Drug | pyrotinib alone, then pyrotinib + Montmorillonite Power or Loperamide |
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 pyrotinib
4 secondary outcomes
PK parameters （Tmax） 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
PK parameters （CL/F） of pyrotinib
Time frame: Day 1 and Day 9
PK parameters （Vz/F） of pyrotinib
Time frame: Day 1 and Day 9
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 23 Dec 2022.
- Derived from this study: PubMed 40433999Wang Y, Li D, Zhang T, Xu S, Zhang Y, Zhao K, Li S, Shen K, Li X, Xu P. Evaluation of the pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib in healthy volunteers. Front Pharmacol. 2025 May 12;16:1563556. doi: 10.3389/fphar.2025.1563556. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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, Montmorillonite Power and Loperamide in people with HER2-positive Recurrent / Metastatic Breast Cancer, 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 21 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 23 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?
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?
On the ClinicalTrials.gov record for NCT05252546, which also lists 1 linked publication.
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 23 Dec 2022; AzTrials last refreshed its copy on 26 Oct 2026.