Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05034120
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Effect and Mass Balance Study of XZP-3621 Tablets
Sponsor:
Xuanzhu Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Study to Investigate the Food Effect on the Pharmacokinetics of XZP-3621 Tablets and the Absorption, Metabolism and Excretion of XZP-3621 in Chinese Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. The stage 2 is to evaluate the effect of food on the Pharmacokinetics of single-dose XZP-3621 tablets in Chinese Healthy Volunteers. In addition, the safety of XZP-3621 tablets in Chinese Healthy Volunteers will also be evaluated.
Detailed Description:
Stage 1: 10 healthy adult subjects will be included in the study. Excretion (feces, urine) and vomit samples will be collected daily and tested for prototype drug and metabolites of XZP-3621, the metabolites will be identified in all substrates except vomits pose-dose of 400 mg XZP-3621 tablets.
Vomit samples collection: Time interval for subject vomit collection (if any) (planned):0\~4 h,4\~8 h,8\~12 h,12\~24 h,24\~48 h,48\~72 h,72\~96 h,96\~120 h,120\~144 h,144\~168 h,168\~192 h after taking single XZP-3621 tablet. Samples of all vomits during that time interval will be collected at each time interval after taking single XZP-3621 tablet.
Urine samples collection: Time interval for sample collection(planned):24h before taking single XZP-3621 tablet,0\~4 h,4\~8 h,8\~12 h,12\~24 h,24\~48 h,48\~72 h,72\~96 h,96\~120 h,120\~144 h,144\~168 h,168\~192 h after taking single XZP-3621 tablet, Urine samples were collected from each subject at a total of 12 time intervals (Only one urine sample should be collected within 24 hours before taking single XZP-3621 tablet), Urine volume was accurately recorded for each time period.
Feces samples collection: Interval of fecal sample collection of subjects (planned):24h before taking single XZP-3621 tablet,0\~24 h,24\~48 h,48\~72 h,72\~96 h,96\~120 h,120\~144 h,144\~168 h,168\~192 h after taking single XZP-3621 tablet. Feces samples will be collected from each subject at a total of 9 time intervals (Only one sample was collected within 24 h before taking single XZP-3621 tablet), And accurate fecal weight will be recorded for each time period.
PK blood sample collection: PK blood samples of subjects will be collected before administration (within 2 h before administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after administration at 18 collection points. Plasma samples for metabolite identification should be separately packaged.
Stage 2: This stage of study will be a randomized, open, three-cycle crossover study to evaluate the pharmacokinetic effects and safety of a single oral dose of XZP-3621 in healthy subjects on a high-fat diet versus a standard diet.
In this study stage, 24 healthy subjects meeting the requirements of the protocol will be planned to be enrolled and randomly divided into groups A, B, C, D, E and F at 1:1:1:1:1:1 , with 4 subjects in each group. Each subject will undergo three cycles of fasting administration, high-fat postprandial administration, and standard postprandial administration (in random order) throughout the study.
PK blood sample collection: PK blood samples will be collected before taking single XZP-3621 tablet (within 2 h before drug administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after taking single XZP-3621 tablet in each cycle, with a total of 18 collection points.
Vomit samples collection: Time interval for subject vomit collection (if any) (planned):0\~4 h,4\~8 h,8\~12 h,12\~24 h,24\~48 h,48\~72 h,72\~96 h,96\~120 h,120\~144 h,144\~168 h,168\~192 h after taking single XZP-3621 tablet. Samples of all vomits during that time interval will be collected at each time interval after taking single XZP-3621 tablet.
Urine samples collection: Time interval for sample collection(planned):24h before taking single XZP-3621 tablet,0\~4 h,4\~8 h,8\~12 h,12\~24 h,24\~48 h,48\~72 h,72\~96 h,96\~120 h,120\~144 h,144\~168 h,168\~192 h after taking single XZP-3621 tablet, Urine samples were collected from each subject at a total of 12 time intervals (Only one urine sample should be collected within 24 hours before taking single XZP-3621 tablet), Urine volume was accurately recorded for each time period.
Feces samples collection: Interval of fecal sample collection of subjects (planned):24h before taking single XZP-3621 tablet,0\~24 h,24\~48 h,48\~72 h,72\~96 h,96\~120 h,120\~144 h,144\~168 h,168\~192 h after taking single XZP-3621 tablet. Feces samples will be collected from each subject at a total of 9 time intervals (Only one sample was collected within 24 h before taking single XZP-3621 tablet), And accurate fecal weight will be recorded for each time period.
PK blood sample collection: PK blood samples of subjects will be collected before administration (within 2 h before administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after administration at 18 collection points. Plasma samples for metabolite identification should be separately packaged.
Stage 2: This stage of study will be a randomized, open, three-cycle crossover study to evaluate the pharmacokinetic effects and safety of a single oral dose of XZP-3621 in healthy subjects on a high-fat diet versus a standard diet.
In this study stage, 24 healthy subjects meeting the requirements of the protocol will be planned to be enrolled and randomly divided into groups A, B, C, D, E and F at 1:1:1:1:1:1 , with 4 subjects in each group. Each subject will undergo three cycles of fasting administration, high-fat postprandial administration, and standard postprandial administration (in random order) throughout the study.
PK blood sample collection: PK blood samples will be collected before taking single XZP-3621 tablet (within 2 h before drug administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after taking single XZP-3621 tablet in each cycle, with a total of 18 collection points.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: