Healthy SubjectsPhase 1NCT06352190
A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China
A Phase 1 study testing [14C] SY-5007 in people with Healthy Subjects, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.
Trial summary
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally. 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 Subjects
- What is being tested?
- [14C] SY-5007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Jun 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled in this study:
- Fully informed, able to communicate effectively with researchers, agree to abide by the protocol and trial management regulations, and voluntarily sign the written Informed Consent Form (ICF);
- Healthy adult males aged 18 to 50 years at the time of signing the ICF, with no plans for reproduction or sperm donation within the past 2 years;
- Weight ≥ 50 kg and body mass index (BMI) between 18 and 26 kg/m2;
- Subjects of reproductive capability agree to employ effective contraceptive measures with their sexual partners during the study period and for 2 years following the end of the study.
Who cannot join
- Subjects meeting any of the following criteria are ineligible for participation in this study:
- History of allergies (such as allergies to two or more drugs, foods, or pollen, or individuals prone to skin hives or allergic reactions).
- Positive for hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, or positive for syphilis treponemal and non-treponemal antibodies during screening.
- Abnormal clinically significant vital signs, physical examinations, laboratory tests, or electrocardiograms at screening.
- Gastrointestinal, hepatic, or renal diseases that may affect drug pharmacokinetics as assessed by the investigator at screening.
- History of drug abuse or illicit drug use within 12 months prior to the first dose administration, or positive urine drug screening test during screening.
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- Underwent major surgery within 6 months prior to the first dose administration, or planned to undergo surgery during the trial period.
- History of any clinically significant illness within 3 months prior to the first dose administration or conditions deemed by the investigator to potentially affect trial outcomes, including but not limited to cardiovascular, endocrine, nervous, respiratory, digestive, urinary, hematologic, immune, or psychiatric disorders.
- Average daily smoking of more than 5 cigarettes within 3 months prior to the first dose administration, or unwillingness to discontinue use of any tobacco products during the trial.
- Regular alcohol consumption within 3 months prior to the first dose administration [defined as consuming more than 14 units of alcohol per week (1 unit = 360mL of 5% alcohol beer or 45mL of 40% alcohol liquor or 150mL of 12% alcohol wine)], or inability to abstain from alcohol during the trial, or positive alcohol breath test during screening.
- History of blood donation or significant blood loss (≥ 300mL) within 3 months prior to the first dose administration, or use of blood products or blood transfusion within 1 month prior to the first dose administration.
- Participation in other drug or medical device clinical trials within 3 months prior to the first dose administration (excluding screen failures), or prior use of the investigational drug.
- Vaccination within 1 month prior to the first dose administration.
- Use of any prescription drugs, over-the-counter drugs, supplements, or herbal remedies within 2 weeks prior to the first dose administration (if the half-life [t1/2] of the drug can be confirmed, a washout period of 5 times of t1/2 is required).
- Habitual consumption of more than 8 cups (1 cup = 250mL) of tea, coffee, or caffeinated beverages and unable to abstain from consumption within 48 hours prior to the first dose administration and during the trial.
- Special dietary requirements or difficulty swallowing.
- Habitual constipation or previous difficulty with bowel movements.
- Difficulty with blood collection, history of fainting with needles, or intolerance to venipuncture.
- Engagement in occupations requiring prolonged exposure to radioactive conditions; or significant exposure to radiation within 1 year prior to the trial (e.g., 2 chest/abdominal CT scans, or 3 other types of X-ray examinations).
- History of definite neurological or psychiatric disorders, including dementia or seizures diagnosed for any reason.
- Other conditions deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Ruihua Dong, MD, 86-010-63139033, ruihua_dong_rw@163.com
About this study
Official title: An Open-Label, Single-Center, Single-Dose, Phase I Study to Assess the Mass Balance of [14C] SY-5007 in Healthy Male Subjects in China
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally.
Read the detailed description
The trial will consist of two parts:
Pilot Study:
Two eligible adult male subjects will be enrolled and admitted to the clinical trial center after passing the inclusion criteria review. They will undergo training on medication administration, urine and feces collection, etc., to ensure compliance with the protocol and standard operating procedures (SOP). Subjects will fast before medication administration and provide urine and feces samples at specified intervals after dosing. Blood samples will also be collected at specified time points.
Formal Study:
Four to six male subjects will be enrolled, receiving a single dose of SY-5007 160 mg orally containinig roughly 120 µCi [14C] SY-5007. Blood, urine and feces samples will be collected at specified time points.
Safety monitoring (12-lead ECG, vital signs, blood chemistry and haematology) and adverse events will be monitored throughout the study.
- Conditions
- Healthy Subjects
- Being tested
- [14C] SY-5007
- Keywords
- [14C] SY-5007, Mass Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] SY-5007Drug
Carbon-14 labeled SY-5007
| Study group | Role | What they receive |
|---|---|---|
| SY-5007 | Experimental | Single oral dose of 160 mg SY-5007 suspension (containing approximately 120 μCi [14C] SY-5007) Receives: Drug: [14C] SY-5007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity in plasma PK: Cmax
Highest radioactivity observed plasma concentration
Measured: At pre-dose and up to 2 weeks post-dose
Total radioactivity in plasma PK: Tmax
Time to reach the Cmax
Measured: At pre-dose and up to 2 weeks post-dose
Total radioactivity in plasma PK: AUC0-t
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Measured: At pre-dose and up to 2 weeks post-dose
Total radioactivity in plasma PK: t½
Defined as apparent plasma terminal phase disposition half-life
Measured: At pre-dose and up to 2 weeks post-dose
Total radioactivity in plasma PK: CL/F
Defined as apparent total body clearance
Measured: At pre-dose and up to 2 weeks post-dose
Whole blood to plasma total radioactivity ratio
To evaluate the extent of distribution of total radioactivity into blood cells
Measured: At pre-dose and up to 2 weeks post-dose
Cumulative total radioactivity in urine and faeces
Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
Measured: At pre-dose and up to 2 weeks post-dose
Metabolic profiling in plasma, urinary and fecal excretion
To characterize the metabolic profile and identify circulating and excreted metabolites of SY-5007 using liquid chromatography with mass spectral detection.
Measured: At pre-dose and up to 2 weeks post-dose
Secondary outcomes (6)
Cmax of SY-5007 and its metabolites
Defined as maximum observed plasma concentration
Measured: At pre-dose and up to 2 weeks post-dose
Tmax of SY-5007 and its metabolites
Defined as time to maximum plasma concentration
Measured: At pre-dose and up to 2 weeks post-dose
AUC0-t of SY-5007 and its metabolites
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Measured: At pre-dose and up to 2 weeks post-dose
t½ of SY-5007 and its metabolites
Defined as apparent plasma terminal phase disposition half-life
Measured: At pre-dose and up to 2 weeks post-dose
CL/F of SY-5007 and its metabolites
Defined as apparent total body clearance
Measured: At pre-dose and up to 2 weeks post-dose
Incidence of adverse events
To evaluate the safety of a single oral dose of 160 mg of SY-5007
Measured: At pre-dose and up to 2 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shouyao Holdings (Beijing) Co. LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinghui Sun, PhD, Study director, Shouyao Holdings (Beijing) Co. LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352190
- Sponsor's protocol ID
- SY-5007-I-04
- Status last verified
- Dec 2023
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 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 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center, Single-Dose, Phase I Study to Assess the Mass Balance of [14C] SY-5007 in Healthy Male Subjects in China
- ClinicalTrials.gov ID
- NCT06352190
- Acronym / sponsor ID
- SY-5007-I-04
- Conditions
- Healthy Subjects
- Keywords
- [14C] SY-5007, Mass Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Shouyao Holdings (Beijing) Co. LTDUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 8 Apr 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, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally.
Detailed description
The trial will consist of two parts:
Pilot Study:
Two eligible adult male subjects will be enrolled and admitted to the clinical trial center after passing the inclusion criteria review. They will undergo training on medication administration, urine and feces collection, etc., to ensure compliance with the protocol and standard operating procedures (SOP). Subjects will fast before medication administration and provide urine and feces samples at specified intervals after dosing. Blood samples will also be collected at specified time points.
Formal Study:
Four to six male subjects will be enrolled, receiving a single dose of SY-5007 160 mg orally containinig roughly 120 µCi [14C] SY-5007. Blood, urine and feces samples will be collected at specified time points.
Safety monitoring (12-lead ECG, vital signs, blood chemistry and haematology) and adverse events will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SY-5007 | Experimental | Drug: [14C] SY-5007Single oral dose of 160 mg SY-5007 suspension (containing approximately 120 μCi [14C] SY-5007) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fully informed, able to communicate effectively with researchers, agree to abide by the protocol and trial management regulations, and voluntarily sign the written Informed Consent Form (ICF);
- Healthy adult males aged 18 to 50 years at the time of signing the ICF, with no plans for reproduction or sperm donation within the past 2 years;
- Weight ≥ 50 kg and body mass index (BMI) between 18 and 26 kg/m2;
- Subjects of reproductive capability agree to employ effective contraceptive measures with their sexual partners during the study period and for 2 years following the end of the study.
Key exclusion criteria (21 listed)
- Subjects meeting any of the following criteria are ineligible for participation in this study:
- History of allergies (such as allergies to two or more drugs, foods, or pollen, or individuals prone to skin hives or allergic reactions).
- Positive for hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, or positive for syphilis treponemal and non-treponemal antibodies during screening.
- Abnormal clinically significant vital signs, physical examinations, laboratory tests, or electrocardiograms at screening.
- Gastrointestinal, hepatic, or renal diseases that may affect drug pharmacokinetics as assessed by the investigator at screening.
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] SY-5007Carbon-14 labeled SY-5007 | Drug | SY-5007 |
Primary outcome
Total radioactivity in plasma PK: Cmax
Time frame: At pre-dose and up to 2 weeks post-dose
Highest radioactivity observed plasma concentration
Total radioactivity in plasma PK: Tmax
Time frame: At pre-dose and up to 2 weeks post-dose
Time to reach the Cmax
Total radioactivity in plasma PK: AUC0-t
Time frame: At pre-dose and up to 2 weeks post-dose
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Total radioactivity in plasma PK: t½
Time frame: At pre-dose and up to 2 weeks post-dose
Defined as apparent plasma terminal phase disposition half-life
Total radioactivity in plasma PK: CL/F
Time frame: At pre-dose and up to 2 weeks post-dose
Defined as apparent total body clearance
Whole blood to plasma total radioactivity ratio
Time frame: At pre-dose and up to 2 weeks post-dose
To evaluate the extent of distribution of total radioactivity into blood cells
Cumulative total radioactivity in urine and faeces
Time frame: At pre-dose and up to 2 weeks post-dose
Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
Metabolic profiling in plasma, urinary and fecal excretion
Time frame: At pre-dose and up to 2 weeks post-dose
To characterize the metabolic profile and identify circulating and excreted metabolites of SY-5007 using liquid chromatography with mass spectral detection.
6 secondary outcomes
Cmax of SY-5007 and its metabolites
Time frame: At pre-dose and up to 2 weeks post-dose
Tmax of SY-5007 and its metabolites
Time frame: At pre-dose and up to 2 weeks post-dose
AUC0-t of SY-5007 and its metabolites
Time frame: At pre-dose and up to 2 weeks post-dose
t½ of SY-5007 and its metabolites
Time frame: At pre-dose and up to 2 weeks post-dose
CL/F of SY-5007 and its metabolites
Time frame: At pre-dose and up to 2 weeks post-dose
Incidence of adverse events
Time frame: At pre-dose and up to 2 weeks post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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, PhD 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 [14C] SY-5007 in people with Healthy 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 8 Apr 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, PhD (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?
Total radioactivity in plasma PK: Cmax (time frame: At pre-dose and up to 2 weeks post-dose). The study lists 8 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 8 Apr 2024.