NCT06306872

A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABSK061 Minitablets Following Single and Multiple Oral Doses and to Assess the Effect of Administration With Soft Foods in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose

Detailed description

This study consists of three separate parts: Part A, Part B and Part C. Part A is designed as a two-period, open-label, two-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose. Part B is designed as a three-period, open-label, three-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new ABSK-011 formulation versus the old formulation at high and low doses for single oral administration. Part C was designed as a four-period, open-label, fixed-sequence study, the main objective of which was to evaluate the effects of low-fat diet, high-fat diet and omeprazole magnesium enteric-coated tablets on PK of the new ABSK-011 formulation after a single oral administration.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Sequence A ABSK-011	Subjects in sequence A will receive 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 200 mg(100 mg capsule \*2) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1).
DRUG	Sequence B ABSK-011	Subjects in sequence A will receive 200 mg(100 mg capsule \*2) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1).

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-03-12
• Last updated: 2025-12-10

Locations

1 site across 1 country: China