Healthy ParticipantsPhase 1NCT06536036
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270
A Phase 1 study testing SIM0270 in people with Healthy Participants, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, open label, single dose, two-period, crossover trial phase I study. The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SIM0270
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 16 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
- Male and female subjects,age 18-65 years
- Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 19 and ≤ 28kg/m^2.
- Subjects of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent.
Who cannot join
- Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, skeletal-muscular disorders , hepatic or renal insufficiency, or any other disease or condition that may affect the results of the study or the safety of the subjects.
- With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
- There are risk factors for apical torsion type ventricular tachycardia, or other clinically significant abnormalities determined by research doctors.
- Have a history of active or latent tuberculosis.
- History of malignant tumors. Excluding cervical carcinoma in situ, non melanoma skin cancer, or stage I uterine cancer (with a disease-free interval of at least 5 years) that have received appropriate treatment.
- Investigator believe that any acute or chronic disease may limit the ability of participants to complete and/or participate in this clinical study.
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- Individuals who are allergic to the research drug or any component of the research drug, have a specific history of allergies, or have an allergic constitution
- Have used hormone replacement therapy or selective estrogen modulators within the year prior to enrollment.
- Have used oral antibiotics within 4 weeks before enrollment or intravenous antibiotics within 8 weeks.
- Any medication/product known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, used or intended to be used within one month prior to enrollment.
- Used any prescription drugs/products within 2 weeks prior to enrollment or any over-the-counter drugs within 1 week prior to enrollment.
- Received CYP3A4 strong inhibitor or strong inducer medication within 2 weeks prior to administration after signing the informed consent form.
- The results of laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), physical examination, vital signs, 12 lead electrocardiogram examination, chest anteroposterior and lateral radiographs, and abdominal ultrasound examination were determined by the researchers to be abnormal and clinically significant.
- Screening period (mean) or baseline electrocardiogram examination shows heart rate<60 or>100 and QTcF interval>450 ms.
- Pregnant women with fertility test results are positive or pregnant or lactating women.
- Those who are positive for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
About this study
Official title: A Single Center, Randomized, Open Label, Single Dose, Two-Period, Crossover Phase I Study to Evaluate the Effect of Food (high-fat/standard Meal) on the Pharmacokinetics of SIM0270 in Healthy Adult Subjects in China
This is a randomized, open label, single dose, two-period, crossover trial phase I study.
The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.
Read the detailed description
Part A High Fat Meal Test:
Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 1 and Group 2) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or high-fat diet conditions.
Part B Standard Meal Test (optional part):
Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 3 and Group 4) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or standard meal conditions.
- Conditions
- Healthy Participants
- Being tested
- SIM0270
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0270Drug
Use according to the prescribed protocol
| Study group | Role | What they receive |
|---|---|---|
| High-fat meal group（Group1） | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under high-fat diet condition in the second cycle. Receives: Drug: SIM0270 |
| High-fat meal group（Group2） | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under high-fat diet condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle. Receives: Drug: SIM0270 |
| Standard meal group（Group3） | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under standard meal condition in the second cycle. Receives: Drug: SIM0270 |
| Standard meal group（Group4） | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under standard meal condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle. Receives: Drug: SIM0270 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters: Peak Plasma Concentration (Cmax)
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
Measured: Day1 to Day 37
PK parameters:Area under the plasma concentration versus time curve (AUC)
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
Measured: Day1 to Day 37
PK parameters: Half-life (t1/2)
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
Measured: Day1 to Day 37
Secondary outcomes (1)
Adverse events
The incidence and grading of adverse events, as well as abnormal indicators of vital signs, physical examination, electrocardiogram, and laboratory tests.
Measured: From signing ICF until 18 days after the last dose of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start23 Jul 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
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 Simcere Pharmaceutical 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Zaiming Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536036
- Sponsor's protocol ID
- SIM0270-102
- Status last verified
- Nov 2024
- First submitted
- 16 Jul 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open Label, Single Dose, Two-Period, Crossover Phase I Study to Evaluate the Effect of Food (high-fat/standard Meal) on the Pharmacokinetics of SIM0270 in Healthy Adult Subjects in China
- ClinicalTrials.gov ID
- NCT06536036
- Acronym / sponsor ID
- SIM0270-102
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Zaiming Pharmaceutical Co., Ltd.
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 2 Aug 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 is a randomized, open label, single dose, two-period, crossover trial phase I study.
The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.
Detailed description
Part A High Fat Meal Test:
Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 1 and Group 2) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or high-fat diet conditions.
Part B Standard Meal Test (optional part):
Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 3 and Group 4) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or standard meal conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-fat meal group（Group1） | Experimental | Drug: SIM0270Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under high-fat diet condition in the second cycle. |
| High-fat meal group（Group2） | Experimental | Drug: SIM0270Eight subjects were enrolled and administered single dose of 60mg SIM0270 under high-fat diet condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle. |
| Standard meal group（Group3） | Experimental | Drug: SIM0270Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under standard meal condition in the second cycle. |
| Standard meal group（Group4） | Experimental | Drug: SIM0270Eight subjects were enrolled and administered single dose of 60mg SIM0270 under standard meal condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
- Male and female subjects,age 18-65 years
- Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 19 and ≤ 28kg/m^2.
- Subjects of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent.
Key exclusion criteria (16 listed)
- Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, skeletal-muscular disorders , hepatic or renal insufficiency, or any other disease or condition that may affect the results of the study or the safety of the subjects.
- With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
- There are risk factors for apical torsion type ventricular tachycardia, or other clinically significant abnormalities determined by research doctors.
- Have a history of active or latent tuberculosis.
- History of malignant tumors. Excluding cervical carcinoma in situ, non melanoma skin cancer, or stage I uterine cancer (with a disease-free interval of at least 5 years) that have received appropriate treatment.
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 |
|---|---|---|
| SIM0270Use according to the prescribed protocol | Drug | High-fat meal group（Group1）, High-fat meal group（Group2）, Standard meal group（Group3）, Standard meal group（Group4） |
Primary outcome
PK parameters: Peak Plasma Concentration (Cmax)
Time frame: Day1 to Day 37
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
PK parameters:Area under the plasma concentration versus time curve (AUC)
Time frame: Day1 to Day 37
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
PK parameters: Half-life (t1/2)
Time frame: Day1 to Day 37
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
1 secondary outcome
Adverse events
Time frame: From signing ICF until 18 days after the last dose of medication
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 2 Dec 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.
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 SIM0270 in people with Healthy Participants, run by Jiangsu Simcere 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 16 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 2 Dec 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?
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?
PK parameters: Peak Plasma Concentration (Cmax) (time frame: Day1 to Day 37). The study lists 3 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 2 Dec 2024.