Healthy Male Subjects
Conditions
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
Interventions
DRUG[14C]XZP-3287
360 mg suspension containing 50µCi of \[14C\] XZP-3287
Sponsors
Xuanzhu Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult males aged 18 to 45 years (inclusive). 2. Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive). 3. No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities. 4. No clinically significant vital signs, physical examination, laboratory tests, ECG findings. 5. No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing. 6. 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
1. 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. 2. History of clinically significant ECG abnormalities or family history of long QT syndrome. 3. History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion. 4. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive. 5. Positive results from urine drug screen test. 6. Donate blood or lose blood 200 mL or more within 1 month prior to dosing. 7. 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. 8. History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces) | 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 |
| PK data for 14C-XZP-3287: Cmax | up to 15 days | Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity |
| PK data for 14C-XZP-3287: AUClast | 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 | 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 | up to 15 days | Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of XZP-3287 in plasma | up to 15 days | Maximum observed concentration for XZP-3287 in plasma |
| AUClast of XZP-3287 in plasma | 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 |
| AUCinf of XZP-3287 in plasma | up to 15 days | Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma |
| Tmax of XZP-3287 in plasma | up to 15 days | Time of maximum observed concentration for XZP-3287 in plasma |
| To evaluate the safety of [14C] XZP-3287 | up to 29 days | Percentage of Participants with Adverse Events (AEs) |
Countries
China
Contacts
Primary ContactCuilan Xiao
Outcome results
None listed