Healthy Male SubjectsPhase 1NCT05478109
A Clinical Trial of XZP-3287 for Material Balance
A Phase 1 study testing [14C]XZP-3287 in people with Healthy Male Subjects, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287 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 Male Subjects
- What is being tested?
- [14C]XZP-3287
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2022to 4 Jan 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
- Healthy adult males aged 18 to 45 years (inclusive).
- Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).
- No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
- No clinically significant vital signs, physical examination, laboratory tests, ECG findings.
- No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.
- Subjects are able to communicate well with the investigators, and be able to complete the trial according to the process, and sign an Informed Consent Form.
Who cannot join
- Subjects with a history of drug allergy, or atopic allergic disease (Asthma, urticaria, eczema dermatitis), or a known history of allergy to the test drug or its adjuvant components.
- History of clinically significant ECG abnormalities or family history of long QT syndrome.
- History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.
- Positive results from urine drug screen test.
- Donate blood or lose blood 200 mL or more within 1 month prior to dosing.
- Subjects who have used any medication, herbal medicine, nutritional supplements or health care products within 4 weeks prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication.
- History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Gaobo Boren Hospital
Beijing, Beijing Municipality, 100070
Fang Hou, +86-10-83605200 ext. 856, houf@gobroadhealthcare.com
About this study
Official title: the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects
A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287
- Conditions
- Healthy Male Subjects
- Being tested
- [14C]XZP-3287
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]XZP-3287Drug
360 mg suspension containing 50µCi of [14C] XZP-3287
| Study group | Role | What they receive |
|---|---|---|
| [14C]XZP-3287 | Experimental | Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287 Receives: Drug: [14C]XZP-3287 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK data for 14C-XZP-3287: Cmax
Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
Measured: up to 15 days
PK data for 14C-XZP-3287: AUClast
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma and whole blood total radioactivity
Measured: up to 15 days
PK data for 14C-XZP-3287: AUCinf
Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity
Measured: up to 15 days
PK data for 14C-XZP-3287: Tmax
Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
Measured: up to 15 days
Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)
Quantitative analysis of total radioactivity in excreta after oral [14C]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways
Measured: up to 15 days
Secondary outcomes (5)
Cmax of XZP-3287 in plasma
Maximum observed concentration for XZP-3287 in plasma
Measured: up to 15 days
AUClast of XZP-3287 in plasma
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma
Measured: up to 15 days
AUCinf of XZP-3287 in plasma
Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma
Measured: up to 15 days
Tmax of XZP-3287 in plasma
Time of maximum observed concentration for XZP-3287 in plasma
Measured: up to 15 days
To evaluate the safety of [14C] XZP-3287
Percentage of Participants with Adverse Events (AEs)
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start2 Aug 2022 (estimated)
- Primary completion4 Jan 2023 (estimated)
- Study completion4 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478109
- Sponsor's protocol ID
- XZP-3287-1004
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 28 Jul 2022
- 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 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05478109
- Acronym / sponsor ID
- XZP-3287-1004
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (estimated)
- Primary completion
- 4 Jan 2023 (estimated)
- Study completion
- 4 Jan 2023 (estimated)
- First posted
- 28 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.
A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]XZP-3287 | Experimental | Drug: [14C]XZP-3287Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult males aged 18 to 45 years (inclusive).
- Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).
- No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
- No clinically significant vital signs, physical examination, laboratory tests, ECG findings.
- No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.
Key exclusion criteria (8 listed)
- Subjects with a history of drug allergy, or atopic allergic disease (Asthma, urticaria, eczema dermatitis), or a known history of allergy to the test drug or its adjuvant components.
- History of clinically significant ECG abnormalities or family history of long QT syndrome.
- History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.
- Positive results from urine drug screen test.
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-3287360 mg suspension containing 50µCi of [14C] XZP-3287 | Drug | [14C]XZP-3287 |
Primary outcome
PK data for 14C-XZP-3287: Cmax
Time frame: up to 15 days
Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: AUClast
Time frame: up to 15 days
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: AUCinf
Time frame: up to 15 days
Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: Tmax
Time frame: up to 15 days
Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)
Time frame: up to 15 days
Quantitative analysis of total radioactivity in excreta after oral [14C]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways
5 secondary outcomes
Cmax of XZP-3287 in plasma
Time frame: up to 15 days
AUClast of XZP-3287 in plasma
Time frame: up to 15 days
AUCinf of XZP-3287 in plasma
Time frame: up to 15 days
Tmax of XZP-3287 in plasma
Time frame: up to 15 days
To evaluate the safety of [14C] XZP-3287
Time frame: up to 29 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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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.
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-3287 in people with Healthy Male Subjects, 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 6 inclusion and 8 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 28 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cuilan Xiao (+86-13699167610, xiaocuilan@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK data for 14C-XZP-3287: Cmax (time frame: up to 15 days). 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 28 Jul 2022.