NCT05280483

ABSK021 Food Effect Study in Healthy Subjects

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	ABSK021 with fed state	25 mg ABSK021 (1x25 mg ABSK021 capsule) with food
DRUG	ABSK021 with fasted state	25 mg ABSK021 (1x25 mg ABSK021 capsule) without food

Timeline

• Start date: 2022-07-23
• Primary completion: 2022-08-31
• Completion: 2023-05-26
• First posted: 2022-03-15
• Last updated: 2024-08-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study