Food Effect and Mass Balance Study of XZP-3621 Tablets

Healthy Clinical Trial

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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT05034120
• Study type: Interventional
• Source: Xuanzhu Biopharmaceutical Co., Ltd.
• Contact: Xingming Fan, MD
• Phone: 0086-18513114991
• Email: fanxingming@xuanzhubio.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 2021
• Completion date: December 2021