Healthy ParticipantsPhase 1NCT06654791
Mass Balance Clinical Trial of SIM0270
A Phase 1 study testing [14C] SIM0270 Oral Preparation in people with Healthy Participants, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- [14C] SIM0270 Oral Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects fully understand the test content, process and possible adverse reactions, voluntarily sign informed consent, have good communication with the researchers, and can complete all the test procedures in accordance with the protocol.
- Chinese male, aged between 18 and 45 years old (including the critical value, subject to the signing of the informed consent).
- Weight ≥50.0kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including the cut-off value).
Who cannot join
- Clinical examination:
- Patients who have undergone physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, thyroid function, coagulation function, urine routine, stool analysis), vision and eye examination (slit-lamp, intraocular pressure and fundus photography), X-ray chest film (anterior and lateral), abdominal B-ultrasound (liver, bile, pancreas, spleen and kidney) and other abnormal examinations with clinical significance;
- Patients with abnormal 12-lead ECG and clinical significance (including but not limited to: complete left bundle branch block; Right bundle branch block; First, second, or third degree heart block), or QTcF > 450 ms after correction using the Fridericia formula (QTcF=QT / {(60/ heart rate)^0.33});
- Hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- Medication history:
- Those who have used prescription drugs, non-prescription drugs, health drugs or live attenuated vaccines including western medicines or proprietary Chinese medicines within 14 days before the screening period;
Show all 27Show fewer
- Those who participated in any clinical trial and received the experimental drug or medical device intervention within 3 months prior to the screening period;
- Any drug with a strong/medium acting inhibitor or a strong/medium acting inducer of CYP3A4 in the 4 weeks prior to enrollment (see Appendix 1).
- Disease history and surgical history:
- Have been or are currently suffering from any clinically serious disease of the cardiovascular system, digestive system, respiratory system, endocrine system, nervous system, hematology, immunology, skin, tumor, psychiatric and metabolic abnormalities, or any other disease or physiological condition that can interfere with the test results;
- The presence of risk factors for Torsade de Pointes (such as a history of heart failure, hypokalemia, or a family history of prolonged QT syndrome), or a history of sick sinus syndrome, or a history of previous myocardial infarction;
- Patients who have undergone major surgery or whose surgical incision has not fully healed within the 6 months prior to the screening period, including but not limited to any surgery with significant bleeding risk, extended period of general anesthesia or open biopsy or significant traumatic injury (except surgery for recovered appendicitis or proctocele);
- Severe allergy, including allergy to the investigational drug or any excipient in the investigational drug, allergy to two or more other drugs or food ingredients;
- Those who have special requirements for diet and cannot comply with a unified diet;
- Perianal disease with regular/bleeding stool;
- Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
- Living habits:
- Irregular or difficult bowel movements, or other circumstances as assessed by the investigator that affect the collection of stool samples;
- Binge drinking or regular drinking in the six months preceding the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or positive alcohol breath test at screening period;
- Smokers who smoked more than 5 cigarettes per day or habitually used nicotine-containing products in the 3 months before the screening period and could not quit during the trial;
- Drug abuse or dependence, urine drug abuse screening positive;
- Habitual drinking of grapefruit juice or excessive tea (more than 8 cups a day, 1 cup =250 mL), excessive intake of caffeine (more than 3 cups a day coffee, 1 cup =250 mL), and unable to abstain during the trial;
- Others:
- Workers who require prolonged exposure to radioactive conditions; Or had significant radiation exposure (≥2 chest/abdominal CT, or ≥3 other types of X-rays) within 1 year prior to the test or participated in a radiopharmaceutically labeled test within 1 year;
- The subject who is fertile has a birth plan or sperm donation plan within 1 year after the signing of the informed consent, or the subject and his or her partner do not agree to take effective contraceptive measures (such as condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.);
- Those who have lost blood or donated blood up to 400 mL within 3 months before the screening period, or received blood transfusions within 1 month;
- Subjects who have any other factors deemed unsuitable for participation in this study by the investigator.
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 Phase I Clinical Study to Evaluate the Mass Balance of [14C]SIM0270 in Healthy Chinese Adult Subjects
This is a single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects.
Read the detailed description
The main objectives of this study were as follows:
- To quantitatively analyze the total radioactivity in excreta of healthy subjects after a single oral administration of [14C]SIM0270, and to obtain the data of human radioactive excretion rate and main excretion routes.
- After a single oral administration of [14C]SIM0270 in healthy subjects, radioactive metabolite profiles in plasma, urine and feces were investigated to identify metabolites, and the metabolic pathway, main metabolites and elimination pathway of SIM0270 in human body were determined.
- The total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of [14C]SIM0270 was quantitatively analyzed, the pharmacokinetic characteristics of total radioactivity in plasma were evaluated, and the distribution of total radioactivity in whole blood and plasma was investigated.
- Conditions
- Healthy Participants
- Being tested
- [14C] SIM0270 Oral Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] SIM0270 Oral PreparationDrug
Use according to the prescribed protocol
| Study group | Role | What they receive |
|---|---|---|
| [14C]SIM0270 group | Other | Single arm study Receives: Drug: [14C] SIM0270 Oral Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]SIM0270 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Following a single oral dose of 60 milligrams/150μCi of [14C]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.
Measured: From Day 1 to Day 44
Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]SIM0270 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Following a single oral dose of 60 milligrams/150μCi of [14C]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.
Measured: From Day 1 to Day 44
Maximum 0bserved Concentration (Cmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: From 0 to 432 hours
Time to Maximum 0served Concentration (Tmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: From 0 to 432 hours
Area Under the Concentration-Time Curve From Time 0 to 432 Hours AUC(0-432), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: From 0 to 432 hours
Terminal Elimination Half-Life (t1/2), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: From 0 to 432 hours
Secondary outcomes (1)
The incidence of Adverse events
The incidence and grading of adverse events
Measured: From signing ICF until 14 days after departure from the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start17 Oct 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT06654791
- Sponsor's protocol ID
- SIM0270-103
- Status last verified
- Nov 2024
- First submitted
- 21 Oct 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Mass Balance of [14C]SIM0270 in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT06654791
- Acronym / sponsor ID
- SIM0270-103
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Zaiming Pharmaceutical Co., Ltd.
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Oct 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 single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects.
Detailed description
The main objectives of this study were as follows:
- To quantitatively analyze the total radioactivity in excreta of healthy subjects after a single oral administration of [14C]SIM0270, and to obtain the data of human radioactive excretion rate and main excretion routes.
- After a single oral administration of [14C]SIM0270 in healthy subjects, radioactive metabolite profiles in plasma, urine and feces were investigated to identify metabolites, and the metabolic pathway, main metabolites and elimination pathway of SIM0270 in human body were determined.
- The total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of [14C]SIM0270 was quantitatively analyzed, the pharmacokinetic characteristics of total radioactivity in plasma were evaluated, and the distribution of total radioactivity in whole blood and plasma was investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]SIM0270 group | Other | Drug: [14C] SIM0270 Oral PreparationSingle arm study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subjects fully understand the test content, process and possible adverse reactions, voluntarily sign informed consent, have good communication with the researchers, and can complete all the test procedures in accordance with the protocol.
- Chinese male, aged between 18 and 45 years old (including the critical value, subject to the signing of the informed consent).
- Weight ≥50.0kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including the cut-off value).
Key exclusion criteria (27 listed)
- Patients who have undergone physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, thyroid function, coagulation function, urine routine, stool analysis), vision and eye examination (slit-lamp, intraocular pressure and fundus photography), X-ray chest film (anterior and lateral), abdominal B-ultrasound (liver, bile, pancreas, spleen and kidney) and other abnormal examinations with clinical significance;
- Patients with abnormal 12-lead ECG and clinical significance (including but not limited to: complete left bundle branch block; Right bundle branch block; First, second, or third degree heart block), or QTcF > 450 ms after correction using the Fridericia formula (QTcF=QT / {(60/ heart rate)^0.33});
- Hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- Those who have used prescription drugs, non-prescription drugs, health drugs or live attenuated vaccines including western medicines or proprietary Chinese medicines within 14 days before the screening period;
- Those who participated in any clinical trial and received the experimental drug or medical device intervention within 3 months prior to the screening period;
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 |
|---|---|---|
| [14C] SIM0270 Oral PreparationUse according to the prescribed protocol | Drug | [14C]SIM0270 group |
Primary outcome
Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]SIM0270 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Time frame: From Day 1 to Day 44
Following a single oral dose of 60 milligrams/150μCi of [14C]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.
Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]SIM0270 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Time frame: From Day 1 to Day 44
Following a single oral dose of 60 milligrams/150μCi of [14C]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.
Maximum 0bserved Concentration (Cmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Time frame: From 0 to 432 hours
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Time to Maximum 0served Concentration (Tmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Time frame: From 0 to 432 hours
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Area Under the Concentration-Time Curve From Time 0 to 432 Hours AUC(0-432), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Time frame: From 0 to 432 hours
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Terminal Elimination Half-Life (t1/2), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Time frame: From 0 to 432 hours
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
1 secondary outcome
The incidence of Adverse events
Time frame: From signing ICF until 14 days after departure from the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- 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.
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 [14C] SIM0270 Oral Preparation 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 3 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]SIM0270 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period (time frame: From Day 1 to Day 44). The study lists 6 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 27 Nov 2024.