NCT05034120

Food Effect and Mass Balance Study of XZP-3621 Tablets

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	XZP-3621	Administer a single dose of XZP-3621 tablet after a low-fat meal.
DRUG	XZP-3621	Cycle1(D1-D9): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
DRUG	XZP-3621	Cycle1(D1-D9) : Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after on an empty stomach in a single dose on Day19.
DRUG	XZP-3621	Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
DRUG	XZP-3621	Cycle1(D1-D9) : Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
DRUG	XZP-3621	Cycle1(D1-D9): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
DRUG	XZP-3621	Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day19.

Timeline

• Start date: 2021-12-23
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2021-09-05
• Last updated: 2025-05-25

Locations

1 site across 1 country: China