NCT06322706

A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021

A Single-Center, Open-Label, Multi-Cycle Study to Evaluate the Pharmacokinetic Profile of Different Doses of ABSK021 Capsules and the Effect of a High-Fat Meal and Omeprazole Enteric-coated Tablets on the Pharmacokinetic Profile of ABSK021 Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects

Detailed description

Part A: in this part, 18 healthy subjects are planned to be enrolled and will be randomized to either Study Sequence A (Sequence A) or Study Sequence B (Sequence B) (with 9 subjects in each sequence) to receive single oral dose of ABSK021 separately for a total of 3 doses, separated by 10 days. Part B: in this part, 18 healthy subjects are planned to be enrolled to receive single oral dose of ABSK021 in a fixed sequence separately for a total of 2 doses. Subjects will receive a single dose of 50 mg ABSK021 Capsules on the morning of Cycle 1 Day 1 (C1D1) under fasting conditions; and 40 mg Omeprazole once daily from Days 1 to 5 of Cycle 2 (C2D1 to C2D5); with the other single oral dose of 50 mg ABSK021 received 2 h after the dose of Omeprazole under fasting conditions on C2D5

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ABSK021	ABSK021 oral
DRUG	Omeprazole	Omeprazole oral

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2024-03-21
• Last updated: 2025-02-18

Locations

1 site across 1 country: China