Health SubjectsPhase 1NCT06325761
A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects
A Phase 1 study testing SY-5007 in people with Health Subjects, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.
Trial summary
This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Subjects
- What is being tested?
- SY-5007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 May 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- Fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate, and sign a written informed consent form (ICF), and be able to follow the protocol requirements to complete the study as healthy subjects.
- Aged ≥18 and ≤55 years old, regardless of gender (including boundary values, based on the time of signing the informed consent form).
- Male subjects with a body weight ≥50kg, female subjects with a body weight ≥45kg, and a body mass index (BMI = weight/height^2, kg/m^2) between 18 and 26 kg/m^2 (including boundary values).
- Female subjects of childbearing potential and all male subjects agree to adopt effective contraception with their sexual partners during the study and for 3 months after the last dose, and have no plans to donate sperm/eggs during the trial and for 3 months after the end of the trial.
Who cannot join
- Subjects will be ineligible for this study if they meet any of the following criteria:
- A clear history of severe allergies, non-allergic drug reactions, or multiple drug allergies, or known hypersensitivity reactions to the investigational drug (active pharmaceutical ingredient or excipients).
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C antibodies, or syphilis treponema antibodies at screening.
- Clinically significant abnormal vital signs, physical examination findings, laboratory test results, or electrocardiogram results at screening.
- Currently suffering from or known by the investigator to have chronic gastrointestinal, liver, or kidney diseases that may affect trial outcomes.
- Any symptoms or medical history of major diseases within the past two years, including but not limited to cardiovascular, hepatic, renal diseases, or other acute or chronic gastrointestinal diseases, respiratory diseases, musculoskeletal diseases, as well as diseases of the blood, endocrine, nervous, or psychiatric systems, or any other conditions or physiological states that may interfere with trial results.
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- Any surgical conditions or conditions that may significantly affect drug absorption, distribution, metabolism, and excretion, or any surgical conditions or conditions that may pose harm to subjects participating in the trial, such as a history of gastrointestinal surgery (gastrectomy, gastrojejunal anastomosis, intestinal resection, etc.), urinary tract obstruction or difficulty in urination, history of digestive tract ulcers, gastrointestinal bleeding, etc. (Subjects who have undergone appendectomy or hernia repair surgery can be enrolled in the study).
- Known or suspected history of drug abuse within the past two years at screening, or drug abuse within the past three months at screening or baseline, or positive drug abuse screening during screening or baseline.
- Underwent major surgery within the past six months before the first dose or planning to undergo surgery during the trial.
- Smoked an average of more than 5 cigarettes per day within the past three months before the first dose or unwilling to stop using any tobacco products during the trial.
- Regularly consumed alcohol within the past three months before the first dose (defined as consuming more than 14 units of alcohol per week, with 1 unit equal to 360 mL of beer with an alcohol content of 5%, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine with an alcohol content of 12%), or unable to stop drinking during the trial, or positive alcohol breath test at screening.
- History of blood donation or significant blood loss (≥300 mL) within the past two years before the first dose, or use of blood products or receiving blood transfusions within the past month before the first dose.
- Participated in other drug or medical device clinical trials within the past three months before the first dose (excluding those screened but ultimately not enrolled), or used the study drug before.
- Received vaccination or inactivated vaccines within the past month before the first dose.
- Used any prescription drugs, non-prescription drugs, health products, or herbal medicines within the past two weeks before the first dose (if the half-life (t1/2) of the drug used can be confirmed, the washout period should be ≥5 t1/2, with the longer one taken).
- Habitually consumed grapefruit juice or excessive amounts (more than 8 cups, 1 cup = 250 mL) of tea, coffee, and/or caffeinated beverages and unable to stop drinking for at least 48 hours before the first dose and during the trial.
- Have special dietary requirements or difficulty swallowing.
- Difficulty in blood sampling, or a history of fainting or intolerance to venipuncture.
- A clear history of neurological or psychiatric disorders, including dementia or epilepsy, etc.
- Diagnosis of malignant tumors within the past five years (excluding cured in situ cancers, such as non-melanoma skin cancers).
- For scientific reasons, compliance reasons, or for the safety of the subjects, the investigator deems it inappropriate for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Li Zheng, 86-28-85423655, zhengli@wchscu.cn
About this study
Official title: A Randomized, Open-label, Single-dose, Two-period, Two-treatment Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of SY-5007 Tablets in Chinese Healthy Subjects
This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.
Read the detailed description
The study consists of two parts: a pilot study and a formal study. The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal (high-fat meal) for Period 1 and on an empty stomach for Period 2, with observation and PK blood sample collection.
The formal study plans to enroll 24 healthy subjects, divided into Groups A and B, each with 12 subjects, receiving a dose of 160 mg. Group A will receive the drug on an empty stomach for Period 1, followed by administration after a meal (high-fat meal) for Period 2, while Group B will follow the reverse sequence. Both groups will adopt a two-period, two-treatment crossover design with a washout period of 7 days. If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007, subsequent trial protocols may be adjusted.
- Conditions
- Health Subjects
- Being tested
- SY-5007
- Keywords
- SY-5007 tablets, Food effect, Two-period crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-5007Drug
SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days
SY-5007Drug
SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days
| Study group | Role | What they receive |
|---|---|---|
| Fasted dosing followed by fed dosing | Experimental | A single oral dose in the fasted state at Period 1 followed by fed dosing at Period 2 Receives: Drug: SY-5007 |
| Fed dosing followed by fasted dosing | Experimental | A single oral dose in the fed state at Period 1 followed by fasted dosing at Period 2 Receives: Drug: SY-5007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for SY-5007
Defined as maximum observed plasma concentration
Measured: Day 1-Day 15
Tmax for SY-5007
Defined as time to maximum plasma concentration
Measured: Day 1-Day 15
AUC0-t for SY-5007
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Measured: Day 1-Day 15
AUC0-∞ for SY-5007
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to infinity
Measured: Day 1-Day 15
t½ for SY-5007
Defined as apparent plasma terminal phase disposition half-life
Measured: Day 1-Day 15
CL/F for SY-5007
Defined as apparent total body clearance
Measured: Day 1-Day 15
Vz/F for SY-5007
Defined as apparent oral Volume of distribution
Measured: Day 1-Day 15
Secondary outcomes (1)
Safety of SY-5007
AE (adverse event) will be summarized by type and severity
Measured: Day 1-Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shouyao Holdings (Beijing) Co. LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinghui Sun, Dr, Study director, Shouyao Holdings (Beijing) Co. LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325761
- Sponsor's protocol ID
- SY-5007-I-02
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 22 Mar 2024
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-period, Two-treatment Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of SY-5007 Tablets in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06325761
- Acronym / sponsor ID
- SY-5007-I-02
- Conditions
- Health Subjects
- Keywords
- SY-5007 tablets, Food effect, Two-period crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shouyao Holdings (Beijing) Co. LTDUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 22 Mar 2024 (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.
This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.
Detailed description
The study consists of two parts: a pilot study and a formal study. The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal (high-fat meal) for Period 1 and on an empty stomach for Period 2, with observation and PK blood sample collection.
The formal study plans to enroll 24 healthy subjects, divided into Groups A and B, each with 12 subjects, receiving a dose of 160 mg. Group A will receive the drug on an empty stomach for Period 1, followed by administration after a meal (high-fat meal) for Period 2, while Group B will follow the reverse sequence. Both groups will adopt a two-period, two-treatment crossover design with a washout period of 7 days. If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007, subsequent trial protocols may be adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted dosing followed by fed dosing | Experimental | Drug: SY-5007A single oral dose in the fasted state at Period 1 followed by fed dosing at Period 2 |
| Fed dosing followed by fasted dosing | Experimental | Drug: SY-5007A single oral dose in the fed state at Period 1 followed by fasted dosing at Period 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- Fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate, and sign a written informed consent form (ICF), and be able to follow the protocol requirements to complete the study as healthy subjects.
- Aged ≥18 and ≤55 years old, regardless of gender (including boundary values, based on the time of signing the informed consent form).
- Male subjects with a body weight ≥50kg, female subjects with a body weight ≥45kg, and a body mass index (BMI = weight/height^2, kg/m^2) between 18 and 26 kg/m^2 (including boundary values).
- Female subjects of childbearing potential and all male subjects agree to adopt effective contraception with their sexual partners during the study and for 3 months after the last dose, and have no plans to donate sperm/eggs during the trial and for 3 months after the end of the trial.
Key exclusion criteria (21 listed)
- A clear history of severe allergies, non-allergic drug reactions, or multiple drug allergies, or known hypersensitivity reactions to the investigational drug (active pharmaceutical ingredient or excipients).
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C antibodies, or syphilis treponema antibodies at screening.
- Clinically significant abnormal vital signs, physical examination findings, laboratory test results, or electrocardiogram results at screening.
- Currently suffering from or known by the investigator to have chronic gastrointestinal, liver, or kidney diseases that may affect trial outcomes.
- Any symptoms or medical history of major diseases within the past two years, including but not limited to cardiovascular, hepatic, renal diseases, or other acute or chronic gastrointestinal diseases, respiratory diseases, musculoskeletal diseases, as well as diseases of the blood, endocrine, nervous, or psychiatric systems, or any other conditions or physiological states that may interfere with trial results.
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 |
|---|---|---|
| SY-5007SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days | Drug | Fasted dosing followed by fed dosing |
| SY-5007SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days | Drug | Fed dosing followed by fasted dosing |
Primary outcome
Cmax for SY-5007
Time frame: Day 1-Day 15
Defined as maximum observed plasma concentration
Tmax for SY-5007
Time frame: Day 1-Day 15
Defined as time to maximum plasma concentration
AUC0-t for SY-5007
Time frame: Day 1-Day 15
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
AUC0-∞ for SY-5007
Time frame: Day 1-Day 15
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to infinity
t½ for SY-5007
Time frame: Day 1-Day 15
Defined as apparent plasma terminal phase disposition half-life
CL/F for SY-5007
Time frame: Day 1-Day 15
Defined as apparent total body clearance
Vz/F for SY-5007
Time frame: Day 1-Day 15
Defined as apparent oral Volume of distribution
1 secondary outcome
Safety of SY-5007
Time frame: Day 1-Day 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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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.
Yinghui Sun, Dr study director
Shouyao Holdings (Beijing) Co. LTD
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 SY-5007 in people with Health Subjects, run by Shouyao Holdings (Beijing) 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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 Yinghui Sun, Dr (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for SY-5007 (time frame: Day 1-Day 15). The study lists 7 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 22 Mar 2024.