Healthy Male VolunteersPhase 1NCT04810533
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
A Phase 1 study testing [14C] SH-1028 in people with Healthy Male Volunteers, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] SH-1028 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- [14C] SH-1028
- 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
- 13 May 2020to 5 Mar 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers between the age of 18 to 50 years old；
- Body weight >=50 kg, Body mass index between 19 and 26 kg/m2 (including 19 and 26 kg/m2);
- Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.;
- Signing the informed consent forms by oneself;
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
Who cannot join
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- Positive test for HBs-Ag, HCV-Ab, HIV-Ab, or syphilis antibody;
- Long-QT syndrome or family history of it, or QTcF interval > 450 mses;
- Allergies, have allergies to drugs or foods; or have known allergies to the components of the drug;
- Those who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study；
- The weekly alcohol consumption was higher than 14 units of alcohol (1 unit=10ml or 8g absolute alcohol. 25 ml 40% liquor, 330ml 5% beers, 175ml 12% grape wine are equal to 1.0, 1.5 and 2.0 units of alcohol respectively) 3 months prior to screening period, or positive test for the alcohol breath test results during screening period；
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- Those have history of drug abuse or taking soft drug (i.e., marihuana); or the results of urine test in drugs were positive;
- Participated in other clinical trials within 3 months before screening;
- Received any drug within 14 days before taking the investigational drug;
- Received any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers- barbiturates, tegretol, phenytoin, rifampicin, hexadecadrol, rifabutin, rifapentini; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, verapamil, imidazoles- antifungal drugs) 30 days prior to screening period；
- History of syncope / needle syncope and intolerable intravenous indwelling needle;
- Those who have undergone major surgery within the first 6 months of the screening period;
- Those who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease；
- Hemorrhoids or perianal disease with regular/perianal bleeding;
- Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations);
- Those who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Nanjing, Jiangsu, 210029
About this study
Official title: A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Subjects
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] SH-1028 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of plasma, urine and feces sampling post-dose. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study.
Read the detailed description
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (88 μCi) of [14C]SH-1028 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete.
- Conditions
- Healthy Male Volunteers
- Being tested
- [14C] SH-1028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] SH-1028Drug
Volunteer will receive a single oral dose of 200 mg/88 uCi [14C]SH-1028 as a solution on Day 1
| Study group | Role | What they receive |
|---|---|---|
| [14C] SH-1028 | Experimental | Volunteers will receive 200 mg [14C] SH-1028 containing a nominal 88 μCi activity, administered by mouth, as a solution. Receives: Drug: [14C] SH-1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in blood and in total, up to Day 15
The distribution of [14C]SH-1028 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered [14C]SH-1028 in healthy male volunteers.
Measured: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs
The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in urine, faeces and in total, up to Day 15.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SH-1028 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.
Measured: Day1 to Day 15
The concentrations of SH-1028, Imp2 and Imp3 in plasma up to Day 15
Quantitive analysis of the concentrations of SH-1028 and Imp2,Imp3 (Metabolites of SH-1028) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
Measured: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs
Proportion of different metabolites
Proportion of different metabolites in healthy volunteers after oral administration of [14C]SH-1028
Measured: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs
Types of adverse events
Types of adverse events assessed by CTCAE v5.0 that occurred during the trial
Measured: Baseline (Day-2) to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start13 May 2020
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Shao, Ph D, Principal investigator, Jiangsu Province Hospital Affiliated to Nanjing Madical University of MedicineWei Liu, M.A, Principal investigator, Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810533
- Sponsor's protocol ID
- SHC013-I-04
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 23 Mar 2021
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04810533
- Acronym / sponsor ID
- SHC013-I-04
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 23 Mar 2021 (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, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] SH-1028 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of plasma, urine and feces sampling post-dose. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study.
Detailed description
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (88 μCi) of [14C]SH-1028 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] SH-1028 | Experimental | Drug: [14C] SH-1028Volunteers will receive 200 mg [14C] SH-1028 containing a nominal 88 μCi activity, administered by mouth, as a solution. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male volunteers between the age of 18 to 50 years old；
- Body weight >=50 kg, Body mass index between 19 and 26 kg/m2 (including 19 and 26 kg/m2);
- Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.;
- Signing the informed consent forms by oneself;
Key exclusion criteria (16 listed)
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- Positive test for HBs-Ag, HCV-Ab, HIV-Ab, or syphilis antibody;
- Long-QT syndrome or family history of it, or QTcF interval > 450 mses;
- Allergies, have allergies to drugs or foods; or have known allergies to the components of the drug;
- Those who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study；
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] SH-1028Volunteer will receive a single oral dose of 200 mg/88 uCi [14C]SH-1028 as a solution on Day 1 | Drug | [14C] SH-1028 |
Primary outcome
The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in blood and in total, up to Day 15
Time frame: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs
The distribution of [14C]SH-1028 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered [14C]SH-1028 in healthy male volunteers.
The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in urine, faeces and in total, up to Day 15.
Time frame: Day1 to Day 15
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SH-1028 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.
The concentrations of SH-1028, Imp2 and Imp3 in plasma up to Day 15
Time frame: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs
Quantitive analysis of the concentrations of SH-1028 and Imp2,Imp3 (Metabolites of SH-1028) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
Proportion of different metabolites
Time frame: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs
Proportion of different metabolites in healthy volunteers after oral administration of [14C]SH-1028
Types of adverse events
Time frame: Baseline (Day-2) to Day 15
Types of adverse events assessed by CTCAE v5.0 that occurred during the trial
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 23 Mar 2021.
- 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.
Feng Shao, Ph D principal investigator
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Wei Liu, M.A principal investigator
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
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] SH-1028 in people with Healthy Male Volunteers, run by Nanjing Sanhome 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 6 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 23 Mar 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?
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?
The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in blood and in total, up to Day 15 (time frame: Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs). 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 23 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.