Healthy Volunteers
Conditions
Keywords
[14C]XZP-3621, Mass Balance
Brief 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.
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).
Interventions
DRUG[14C]XZP-3621
Extemporaneously compounded oral suspension solution of \[14C\]XZP-3621 (400 mg/200 µCi)
Sponsors
Xuanzhu Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: A subject will be eligible for study participation if he meets the following criteria: 1. healthy male volunteers between the ages of 18 to 45 years old, inclusive 18 and 45; 2. Body weight \>=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive); 3. 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; 4. Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Exclusion criteria
* A subject will not be eligible for study participation if he meets any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic profiling for XZP-3621 will be determined in plasma, urine and fecal samples | 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. |
| Total recovery of radioactivity in urine and feces | 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 | Assessments will be made up to 19 days post dose | Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample |
| The terminal elimination half life in plasma will be estimated from plasma profiles over time for XZP-3621, metabolite and total radioactivity | 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 |
| Maximum exposure in plasma will be determined for XZP-3621, XZP-5089 metabolite and total radioactivity | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Assessments will be made up to 28 days post dose | According to CTCAE v5.0, the number and frequency of adverse events after a single dose of \[14C\]XZP-3621 were assessed. |
Countries
China
Contacts
Primary ContactBingfeng Wang
Outcome results
None listed