A Clinical Trial of XZP-3287 for Material Balance

Study Overview
=================
Brief Summary
-----------------
A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287

Official Title
-----------------
the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: [14C]XZP-3287


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]XZP-3287<br>Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287 | Drug: [14C]XZP-3287<br>* 360 mg suspension containing 50µCi of [14C] XZP-3287<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK data for 14C-XZP-3287: Cmax | Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity | 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 | 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 | 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 | 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 | up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of XZP-3287 in plasma | Maximum observed concentration for XZP-3287 in plasma | 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 | 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 | up to 15 days | 
| Tmax of XZP-3287 in plasma | Time of maximum observed concentration for XZP-3287 in plasma | up to 15 days | 
| To evaluate the safety of [14C] XZP-3287 | Percentage of Participants with Adverse Events (AEs) | up to 29 days |