Healthy VolunteersPhase 1NCT05836805
A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human
A Phase 1 study testing [14C]XZP-3621 in people with Healthy Volunteers, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, metabolism, safety and tolerability of a single oral dose of [14C]XZP-3621 in healthy volunteers. 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 Volunteers
- What is being tested?
- [14C]XZP-3621
- 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
- May 2023to Sep 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject will be eligible for study participation if he meets the following criteria:
- healthy male volunteers between the ages of 18 to 45 years old, inclusive 18 and 45;
- Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
- 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 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others;
- Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Who cannot join
- A subject will not be eligible for study participation if he meets any of the exclusion criteria:
- Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the test drug;
- Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start;
- Clinically significant of ophthalmologic examinations;
- Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
- History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
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- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease,Hemorrhoids or perianal disease with regular/perianal bleeding;
- Received major surgery within 6 months prior to the screening period or surgical incisions were not fully healed;
- Smoking (> 5 cigarette / day), drinking (> 14 units, pure alcohol / week, equivalent to 360 ml beer/unit, or 45 ml low-alcohol liquor) within 3 months prior to the screening period or Positive screening tests for alcohol,Subjects should avoid smoking and drinking during the clinical trail;
- Participation in an investigational drug or device study within 3 months prior to screening period;
- Subjects who have participated in radiolabeled clinical study within 1 year prior to screening period;
- History of abusing drugs(MOP, METmAMP, MTD, THC, AMP positive) within 1 year prior to screening period;
- Have donated 400ml or more of blood or plasma 3 months prior to the study drug administration;
- Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug or herbal drug;
- Use of any metabolic inducers (including herbals such as St. John's Wort) or inhibitors within 14 days before the first dose of study medication;
- Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
- Vaccination was administered within 1 months prior to screening or during screening;
- Significant radiation exposure within one year prior to drug administration (more than 2 exposures from chest X-ray or CT scan, or barium meal examination and radiation-related occupations);
- Investigators think that subjects are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Suzhou Universiy
Suzhou, Jiangsu, 215006
Liyan Miao, DPH, +86-051267972858, miaolysuzhou@163.com
About this study
Official title: A Phase 1,Single-center,Open-label Study Investigating the Mass Balance,Pharmacokinetics and Metabolism of [14C]XZP-3621 in Healthy Male Subjects
This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, metabolism, safety and tolerability of a single oral dose of [14C]XZP-3621 in healthy volunteers.
Read the detailed description
This open-label, radiolabeled, single 400-mg dose study in approximately 6 healthy male volunteers has been designed to further the understanding of human metabolism of XZP-3621.
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 performed baseline examination and trained on procedures such as medicine-taking, PK blood collection, urine and fecal collection, etc., to ensure that the procedures can be performed according to the protocols and standard operating procedures. And after an overnight fast of at least 10 h, 30 minutes afer a standard meal, subjects will receive a single oral dose of 400 mg (200 μCi) of [14C]XZP-3621 as an oral suspension. Water will be banned from 1 hour pre-dose to 1 hour post-dose (excluding when taking the medicine) and food will be banned within 4 hours post-dose.
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the early release criteria is met. The early release criteria are: 1) recovery in excreta of at least 80% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days).
- Conditions
- Healthy Volunteers
- Being tested
- [14C]XZP-3621
- Keywords
- [14C]XZP-3621, Mass Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]XZP-3621Drug
Extemporaneously compounded oral suspension solution of [14C]XZP-3621 (400 mg/200 µCi)
| Study group | Role | What they receive |
|---|---|---|
| [14C]XZP-3621 | Experimental | Eligible healthy 6 volunteers will receive a single oral dose of 400 mg/200 µCi [14C]XZP-3621 administered by mouth, as a suspension solution. Receives: Drug: [14C]XZP-3621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of radioactivity in urine and feces
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.
Measured: Assessments will be made up to 19 days post dose
Radioactivity concentration of each plasma sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
Measured: Assessments will be made up to 19 days post dose
Metabolic profiling for XZP-3621 will be determined in plasma, urine and fecal samples
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Measured: Assessments will be made up to 19 days post dose
Maximum exposure in plasma will be determined for XZP-3621, XZP-5089 metabolite and total radioactivity
Cmax (maximum observed plasma concentration) will be reported directly from each analyte's data
Measured: Assessments will be made up to 19 days post dose
The overall exposure in plasma will be determined for XZP-3621, metabolite and total radioactivity
AUC0-∞ (Area under the plasma concentration time profile from time 0 extrapolated to infinite time) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for each analyte
Measured: Assessments will be made up to 19 days post dose
The terminal elimination half life in plasma will be estimated from plasma profiles over time for XZP-3621, metabolite and total radioactivity
t1/2 (apparent terminal elimination half life) will be estimated for each analyte from the terminal portion of its plasma concentration versus time plot
Measured: Assessments will be made up to 19 days post dose
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
According to CTCAE v5.0, the number and frequency of adverse events after a single dose of [14C]XZP-3621 were assessed.
Measured: Assessments will be made up to 28 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study startMay 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, DPH, Principal investigator, First Affiliated Hospital of Suzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836805
- Sponsor's protocol ID
- XZP-3621-1004
- Status last verified
- Jan 2023
- First submitted
- 19 Apr 2023
- Last updated
- 1 May 2023
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1,Single-center,Open-label Study Investigating the Mass Balance,Pharmacokinetics and Metabolism of [14C]XZP-3621 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05836805
- Acronym / sponsor ID
- XZP-3621-1004
- Conditions
- Healthy Volunteers
- Keywords
- [14C]XZP-3621, Mass Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 1 May 2023 (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 non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, metabolism, safety and tolerability of a single oral dose of [14C]XZP-3621 in healthy volunteers.
Detailed description
This open-label, radiolabeled, single 400-mg dose study in approximately 6 healthy male volunteers has been designed to further the understanding of human metabolism of XZP-3621.
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 performed baseline examination and trained on procedures such as medicine-taking, PK blood collection, urine and fecal collection, etc., to ensure that the procedures can be performed according to the protocols and standard operating procedures. And after an overnight fast of at least 10 h, 30 minutes afer a standard meal, subjects will receive a single oral dose of 400 mg (200 μCi) of [14C]XZP-3621 as an oral suspension. Water will be banned from 1 hour pre-dose to 1 hour post-dose (excluding when taking the medicine) and food will be banned within 4 hours post-dose.
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the early release criteria is met. The early release criteria are: 1) recovery in excreta of at least 80% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]XZP-3621 | Experimental | Drug: [14C]XZP-3621Eligible healthy 6 volunteers will receive a single oral dose of 400 mg/200 µCi [14C]XZP-3621 administered by mouth, as a suspension solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy male volunteers between the ages of 18 to 45 years old, inclusive 18 and 45;
- Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
- 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 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others;
- Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Key exclusion criteria (20 listed)
- A subject will not be eligible for study participation if he meets any of the exclusion criteria:
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]XZP-3621Extemporaneously compounded oral suspension solution of [14C]XZP-3621 (400 mg/200 µCi) | Drug | [14C]XZP-3621 |
Primary outcome
Total recovery of radioactivity in urine and feces
Time frame: Assessments will be made up to 19 days post dose
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.
Radioactivity concentration of each plasma sample
Time frame: Assessments will be made up to 19 days post dose
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
Metabolic profiling for XZP-3621 will be determined in plasma, urine and fecal samples
Time frame: Assessments will be made up to 19 days post dose
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Maximum exposure in plasma will be determined for XZP-3621, XZP-5089 metabolite and total radioactivity
Time frame: Assessments will be made up to 19 days post dose
Cmax (maximum observed plasma concentration) will be reported directly from each analyte's data
The overall exposure in plasma will be determined for XZP-3621, metabolite and total radioactivity
Time frame: Assessments will be made up to 19 days post dose
AUC0-∞ (Area under the plasma concentration time profile from time 0 extrapolated to infinite time) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for each analyte
The terminal elimination half life in plasma will be estimated from plasma profiles over time for XZP-3621, metabolite and total radioactivity
Time frame: Assessments will be made up to 19 days post dose
t1/2 (apparent terminal elimination half life) will be estimated for each analyte from the terminal portion of its plasma concentration versus time plot
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Assessments will be made up to 28 days post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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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.
Liyan Miao, DPH principal investigator
First Affiliated Hospital of Suzhou Medical College
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]XZP-3621 in people with Healthy Volunteers, run by Xuanzhu Biopharmaceutical 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 20 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 1 May 2023. 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 Bingfeng Wang (+86-13117522385, wangbingfeng@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total recovery of radioactivity in urine and feces (time frame: Assessments will be made up to 19 days post dose). 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 1 May 2023.