Food-drug InteractionPhase 1NCT04673474
A Food-Effect Study of Hemay022 in Healthy Participants
A Phase 1 study testing Hemay022 in people with Food-drug Interaction, run by Tianjin Hemay Oncology Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Food-drug Interaction
- What is being tested?
- Hemay022
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2020to May 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40 years old, the ratio of male to female is 1:1, the age difference of the same batch of subjects is less than 10 years;
- Weight: male should not be less than 50kg, female should be no less than 45kg, body mass index (BMI) [=weight (kg)/height 2 (m2)] between 19-24 (including boundary values);
- 90mmHg≤systolic blood pressure≤140mmHg, 60mmHg≤diastolic blood pressure≤90 mmHg, 55 beats/min≤pulse≤100 beats/min, 12 breaths/min≤respiration≤24 breaths/min, normal body temperature;
- Before the trial, the subjects have understood the nature, significance, possible benefits and possible inconveniences and potential dangers of the trial in detail, and volunteered to participate in the clinical trial, can communicate well with the investigator, comply with the requirements of the entire study, and Signed a written informed consent form.
Who cannot join
- Participated in other drug clinical trials within 3 months;
- (Inquiry)Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones;
- (Inquiry)Those who have a history of severe vomiting, diarrhea or any other diseases or physiological conditions that can interfere with the study results within 7 days before the trial;
- (Inquiry)People with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (such as those who are allergic to two or more drugs, food or pollen), or those who are known to be allergic to tiniba drugs;
- (Inquiry) Those who lost blood or donated more than 400ml of blood within 3 months before this clinical trial, or plan to donate blood during the trial;
- Inquiry) Pregnant or lactating female, or subjects (including male subjects) have a childbirth plan or sperm donation plan within 3 months after the last dose, unwilling or unwilling Those who take effective contraceptive measures;
Show all 25Show fewer
- General physical examination and laboratory examination (blood routine, stool routine, blood biochemistry, coagulation function, urine routine, blood human chorionic gonadotropin/urinary pregnancy (female), etc.) within 7 days before the test, 6 months before the test The result of internal chest radiograph is judged by clinicians as abnormal and clinically significant;
- Subjects whose left ventricular ejection fraction (LVEF) measured by MUGA scan or echocardiography is less than 50%;
- Patients with clinically significant ECG abnormalities in the 14 days before the test, including: QTc (corrected by bazett or fridericia) interval prolonged (≥450ms) on the screening ECG, QRS>120ms;
- One or more test results of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or Treponema pallidum antibody are positive;
- (Inquiry) Those who have suffered from a clinically significant disease or have undergone major surgery within 3 months before the trial;
- (Inquiry) Drinking more than 14 units per week (1 unit = 17.7 mL ethanol, ie 1 unit = 357 mL of beer with 5% alcohol content or 43 mL of liquor with 40% alcohol content or 147 mL of wine with 12% alcohol content), or those who cannot abstain from alcohol during the test;
- (Inquiry) Those who smoked more than 5 cigarettes a day on average in the 3 months before the test, or who could not stop using any tobacco products during the test;
- (Inquiry) People who drank excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) during the 3 months before screening;
- (Inquiry) Have taken grapefruit (including grapefruit), pomegranate, lime, carambola, dragon fruit, mango and other fruits or food or beverages prepared therefrom within 7 days before screening;
- (Inquiry) People who have eaten chocolate, caffeine-rich, xanthine-rich food or beverages and other special diets that affect drug absorption, distribution, metabolism, and excretion during the period from screening to -1 day;
- (Inquiry) Those who cannot eat or have difficulty swallowing, have special dietary requirements and/or cannot follow a unified diet;
- (Inquiry) Those who have a history of asthma or seizures;
- (Inquiry) Those who have used any drugs within 1 month before the trial;
- (Inquiries) Machine operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators;
- (Inquiry) Those who cannot tolerate venipuncture and/or have a history of fainting blood and needles;
- (Inquiry) People with a history of hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- (Inquiry) Those who have used any drugs within one year before the trial;
- Alcohol breath test results greater than 0.0mg/100ml or those who are positive for drug abuse screening (morphine, methamphetamine, ketamine, amphetamine, tetrahydrocannabinol acid, cocaine) );
- Subjects considered by the investigator to have poor compliance or have any factors that are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan
weiyong Li, Ph.D., 86-27-85726685, 2621239868@qq.com
About this study
Official title: A PhaseⅠFood-Effect Study of Hemay022 in Healthy Subjects
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.
- Conditions
- Food-drug Interaction
- Being tested
- Hemay022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay022Drug
Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Hemay022Drug
Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Hemay022 Period 1, Fasted control → Period 2, Fed control Receives: Drug: Hemay022 |
| Arm B | Experimental | Hemay022 Period 1, Fed control → Period 2, Fasted control Receives: Drug: Hemay022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration for Hemay022
Measured: Day 1: 0-48 hours; Day 8: 0-48 hours
Tmax
Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Hemay022
Measured: Day 1: 0-48 hours; Day 8: 0-48 hours
AUC0-t
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Hemay022
Measured: Day 1: 0-48 hours; Day 8: 0-48 hours
AUC0-∞
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for Hemay022
Measured: Day 1: 0-48 hours; Day 8: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start9 Dec 2020
- Primary completion4 Feb 2021
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food-drug InteractionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Oncology Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673474
- Sponsor's protocol ID
- HM022BC1S02
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 20 Apr 2021
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅠFood-Effect Study of Hemay022 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04673474
- Acronym / sponsor ID
- HM022BC1S02
- Conditions
- Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tianjin Hemay Oncology Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 17 Dec 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 this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Hemay022Hemay022 Period 1, Fasted control → Period 2, Fed control |
| Arm B | Experimental | Drug: Hemay022Hemay022 Period 1, Fed control → Period 2, Fasted control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-40 years old, the ratio of male to female is 1:1, the age difference of the same batch of subjects is less than 10 years;
- Weight: male should not be less than 50kg, female should be no less than 45kg, body mass index (BMI) [=weight (kg)/height 2 (m2)] between 19-24 (including boundary values);
- 90mmHg≤systolic blood pressure≤140mmHg, 60mmHg≤diastolic blood pressure≤90 mmHg, 55 beats/min≤pulse≤100 beats/min, 12 breaths/min≤respiration≤24 breaths/min, normal body temperature;
- Before the trial, the subjects have understood the nature, significance, possible benefits and possible inconveniences and potential dangers of the trial in detail, and volunteered to participate in the clinical trial, can communicate well with the investigator, comply with the requirements of the entire study, and Signed a written informed consent form.
Key exclusion criteria (25 listed)
- Participated in other drug clinical trials within 3 months;
- (Inquiry)Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones;
- (Inquiry)Those who have a history of severe vomiting, diarrhea or any other diseases or physiological conditions that can interfere with the study results within 7 days before the trial;
- (Inquiry)People with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (such as those who are allergic to two or more drugs, food or pollen), or those who are known to be allergic to tiniba drugs;
- (Inquiry) Those who lost blood or donated more than 400ml of blood within 3 months before this clinical trial, or plan to donate blood during the trial;
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 |
|---|---|---|
| Hemay022Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods. | Drug | Arm A |
| Hemay022Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods. | Drug | Arm B |
Primary outcome
Cmax
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
Maximum Observed Plasma Concentration for Hemay022
Tmax
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Hemay022
AUC0-t
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Hemay022
AUC0-∞
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for Hemay022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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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.
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 Hemay022 in people with Food-drug Interaction, run by Tianjin Hemay Oncology Pharmaceutical 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 25 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 20 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingxue Lv (＋86-22-24929667, lvyingxue@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1: 0-48 hours; Day 8: 0-48 hours). The study lists 4 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 20 Apr 2021.