ABSK021 Food Effect Study in Healthy Subjects

Neoplasms Clinical Trial

Official title: A Randomized, Open-label, Two-sequence, Two-cycle, Cross-over Study to Evaluate the Relative Bioavailability of ABSK021 After Single-dose Fasting and High-fat Postprandial Administration in Healthy Subjects

Status Not yet recruiting

Clinical Trial Summary

This is a randomized, open-label, two-sequence, two-cycle, cross-over study to evaluate the relative bioavailability of ABSK021 after single-dose fasting and high-fat postprandial administration in healthy subjects

Clinical Trial Description

This is a single-center, arandomized, open label, two-sequence, two-cycle, cross-over study. Up to 16 healthy subjects will be enrolled in this study. Subjects will be randomized into sequence A or sequence B (8 subjects in each study sequence), and receive single oral doses of ABSK021 on 2 occasions separated by a washout period of at least 14 days (7 half-life of ABSK021 in human). Screening will occur up to 28 days prior to the first dose. And the end of treatment visit will occur 14 days after the last dose of ABSK021. ;

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT05280483
• Study type: Interventional
• Source: Abbisko Therapeutics Co, Ltd
• Contact: Ming Zhang
• Phone: +86-21-68912098
• Email: ming.zhang@abbisko.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 19, 2022
• Completion date: June 30, 2022