NCT05533788

ABSK091 Food Effect Study in Healthy Subjects

A Randomized, Open-label, Two Sequence, Two-period Cross-over Study Evaluating the Relative Bioavailability of ABSK091 Single Dose Between Fed and Fasted States in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of a high-fat meal on the rate and extent of absorption and exposure. Study ABSK091-101 is a single-center, Phase 1, open-label, randomized, two-period, two-sequence, and crossover study in healthy subjects.

Conditions

• Health, Subjective
• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	ABSK091 tablet	ABSK091 tablet which is being developed for the treatment of patients with advanced solid tumors

Timeline

• Start date: 2020-09-08
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2022-09-09
• Last updated: 2022-09-09

Locations

1 site across 1 country: Taiwan