Healthy Male VolunteersPhase 1NCT05475834
Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
A Phase 1 study testing SIM0417 in people with Healthy Male Volunteers, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- SIM0417
- 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
- 21 Jul 2022to 7 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent.
- Healthy male subjects aged ≥18 years and ≤55 years old.
- Body weight ≥50 kg, body mass index ≥19 kg/m2 and ≤28 kg/m2.
- Subjects agree to take recognized effective contraceptive measures during the study period and within 3 months after the last dose of the study drug, starting from signing the informed consent.
Who cannot join
- Any diseases that may affect the study results or the safety and status of the subjects, including but not limited to the central nervous system, respiratory system, cardiovascular system, alimentary system, blood and lymphatic system, endocrine system, musculoskeletal system, hepatic and kidney function obstacle.
- Difficulty in venous blood collection, a history of fainting blood or needles, or those who cannot tolerate blood collection with intravenous indwelling needles.
- With dysphagia or any history of gastrointestinal diseases that affect drug absorption/metabolism/excretion (including habitual constipation or diarrhea, perianal disease or hematochezia, irritable bowel syndrome, inflammatory bowel disease, etc.).
- Have special requirements for diet and cannot comply with the provided diet and corresponding regulations.
- With specific allergic history ( asthma, urticaria, eczema, etc. ) or allergic constitution ( such as those allergic to two or more drugs, food such as milk, and pollen ) are allergic to any component of the research drug or research drug.
- Have taken special diet ( including of pitaya, mango, grapefruit, food or beverage containing caffeine, etc. ) or intense exercise within 48 h before the first administration of the drug.
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- Any prescription, non-prescription, vitamin, or herbal medicine was taken within 4 weeks before and during the screening period.
- During the first 3 months prior to screening or from the screening period to the first administration period, alcohol was often consumed, i.e., more than 2 units of alcohol per day ( 1 unit = 360 mL beer or 45 mL spirits with 40 % alcohol or 150 mL wine ); or alcohol breath test positive.
- More than 5 cigarettes per day during the 3 months prior to screening.
- Participated in any drug clinical trial as a subject within 3 months prior to screening and took the study drug.
- With blood donation or blood loss was greater than 200 mL within 3 months prior to screening, or blood transfusion or blood products were received within 4 weeks.
- Have a history of drug abuse or be positive in drug abuse screening test.
- At the time of screening, the blood pressure in the resting state and the pulse are within the following ranges: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm.
- Electrocardiographic QTc > 450 msec (Fridericia formula) at screening, or presence of risk factors for Torsade de Pointes (eg, history of heart failure, history of hypokalemia, family with prolonged QT syndrome) history), or other abnormal clinical significance (judged by the investigator).
- HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening.
- Physical examination, vital signs, blood routine, blood biochemistry ( serum creatinine > 1.0 × ULN )), coagulation function, thyroid function, urine examination, chest X-ray, abdominal B-scan ultrasonography, thyroid B-scan ultrasonography results were abnormal and have clinical significance (judged by the investigator).
- Those who have been vaccinated within 1 month before screening (except for the novel coronavirus vaccine), or who plan to be vaccinated during treatment / within 2 weeks after the last dose of study drug.
- Be positive in SARS-CoV-2 nucleic acid test at screening.
- Subjects have other conditions that are not suitable for participating in this research, or the subjects may not be able to complete this research for other reasons (judged by the investigator).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Investigate The Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir.
Read the detailed description
This is a single-center, non-randomized, open-label, single-cohort, single-dose, Phase I clinical study to evaluate the mass balance, biotransformation, safety, and tolerability of SIM0417 following a single oral administration of SIM0417 combination with ritonavir in healthy Chinese adult male subjects.
This study is planned to enroll 6-8 healthy male subjects, each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12h), at the time of SIM0417 administration (0h), 12h (12h), and 24h (24h) after SIM0417 administration.
SIM0417 is administered after meals, ritonavir is administered either in fasting condition or after meals.
- Conditions
- Healthy Male Volunteers
- Being tested
- SIM0417
- Keywords
- Mass Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0417Drug
Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.
| Study group | Role | What they receive |
|---|---|---|
| SIM0417 | Experimental | Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir. Receives: Drug: SIM0417 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of SIM0417-related substances in urine
Total recovery of SIM0417-related substances in urine after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)
Measured: Up to 168 hours(approx) from SIM0417 administration
Total recovery of SIM0417-related substances in feces
Total recovery of SIM0417-related substances in feces after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)
Measured: Up to 168 hours(approx) from SIM0417 administration
Identification of metabolites in plasma
Identification of metabolites in plasma (if applicable), to identification of major biotransformation pathways
Measured: Up to 72 hours (approx) from SIM0417 administration
Identification of metabolites in urine
Identification of metabolites in urine (if applicable), to identification of major biotransformation pathways
Measured: Up to 168 hours (approx) from SIM0417 administration
Identification of metabolites in feces
Identification of metabolites in feces (if applicable), to identification of major biotransformation pathways
Measured: Up to 168 hours (approx) from SIM0417 administration
Secondary outcomes (4)
Adverse Events
Number of Participants With Adverse Events
Measured: Up to 14 days from SIM0417 administration
Vital Signs
Number of Participants With Clinically Notable Vital Signs
Measured: Up to 8 days from SIM0417 administration
ECG
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Measured: Up to 8 days from SIM0417 administration
Laboratory Tests
Number of Participants With Clinically Notable Laboratory Tests
Measured: Up to 8 days from SIM0417 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start21 Jul 2022
- Primary completion7 Aug 2022
- Study completion7 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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)
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475834
- Sponsor's protocol ID
- SIM0417-104
- Status last verified
- Sep 2022
- First submitted
- 20 Jul 2022
- Last updated
- 3 Oct 2022
- Results posted
- 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 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate The Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
- ClinicalTrials.gov ID
- NCT05475834
- Acronym / sponsor ID
- SIM0417-104
- Conditions
- Healthy Male Volunteers
- Keywords
- Mass Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 7 Aug 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 27 Jul 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.
This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir.
Detailed description
This is a single-center, non-randomized, open-label, single-cohort, single-dose, Phase I clinical study to evaluate the mass balance, biotransformation, safety, and tolerability of SIM0417 following a single oral administration of SIM0417 combination with ritonavir in healthy Chinese adult male subjects.
This study is planned to enroll 6-8 healthy male subjects, each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12h), at the time of SIM0417 administration (0h), 12h (12h), and 24h (24h) after SIM0417 administration.
SIM0417 is administered after meals, ritonavir is administered either in fasting condition or after meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIM0417 | Experimental | Drug: SIM0417Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent.
- Healthy male subjects aged ≥18 years and ≤55 years old.
- Body weight ≥50 kg, body mass index ≥19 kg/m2 and ≤28 kg/m2.
- Subjects agree to take recognized effective contraceptive measures during the study period and within 3 months after the last dose of the study drug, starting from signing the informed consent.
Key exclusion criteria (19 listed)
- Any diseases that may affect the study results or the safety and status of the subjects, including but not limited to the central nervous system, respiratory system, cardiovascular system, alimentary system, blood and lymphatic system, endocrine system, musculoskeletal system, hepatic and kidney function obstacle.
- Difficulty in venous blood collection, a history of fainting blood or needles, or those who cannot tolerate blood collection with intravenous indwelling needles.
- With dysphagia or any history of gastrointestinal diseases that affect drug absorption/metabolism/excretion (including habitual constipation or diarrhea, perianal disease or hematochezia, irritable bowel syndrome, inflammatory bowel disease, etc.).
- Have special requirements for diet and cannot comply with the provided diet and corresponding regulations.
- With specific allergic history ( asthma, urticaria, eczema, etc. ) or allergic constitution ( such as those allergic to two or more drugs, food such as milk, and pollen ) are allergic to any component of the research drug or research drug.
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 |
|---|---|---|
| SIM0417Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir. | Drug | SIM0417 |
Primary outcome
Total recovery of SIM0417-related substances in urine
Time frame: Up to 168 hours(approx) from SIM0417 administration
Total recovery of SIM0417-related substances in urine after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)
Total recovery of SIM0417-related substances in feces
Time frame: Up to 168 hours(approx) from SIM0417 administration
Total recovery of SIM0417-related substances in feces after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)
Identification of metabolites in plasma
Time frame: Up to 72 hours (approx) from SIM0417 administration
Identification of metabolites in plasma (if applicable), to identification of major biotransformation pathways
Identification of metabolites in urine
Time frame: Up to 168 hours (approx) from SIM0417 administration
Identification of metabolites in urine (if applicable), to identification of major biotransformation pathways
Identification of metabolites in feces
Time frame: Up to 168 hours (approx) from SIM0417 administration
Identification of metabolites in feces (if applicable), to identification of major biotransformation pathways
4 secondary outcomes
Adverse Events
Time frame: Up to 14 days from SIM0417 administration
Vital Signs
Time frame: Up to 8 days from SIM0417 administration
ECG
Time frame: Up to 8 days from SIM0417 administration
Laboratory Tests
Time frame: Up to 8 days from SIM0417 administration
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 3 Oct 2022.
- 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.
Wei Zhao principal investigator
Shandong First Medical University
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 SIM0417 in people with Healthy Male Volunteers, 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 19 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 3 Oct 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?
Total recovery of SIM0417-related substances in urine (time frame: Up to 168 hours(approx) from SIM0417 administration). The study lists 5 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 3 Oct 2022.