NCT05433896

Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions

An Open Label, Non-Randomized, Two-Treatment, Single-Period, Single-Dose, Drug-Drug Interaction Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) 90 mg Film-Coated Tablets in Healthy Adult Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Xspray Pharma AB · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

In this open label, single-sequence study, subjects received one dose of XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation at the start of study on Day 1 and Day 6. Omeprazole 40 mg was administered on Day 2, 3, 4, 5 and 6. The study was conducted in two groups.

Conditions

• Pharmacokinetics
• Drug Interactions

Interventions

Type	Name	Description
DRUG	Dasatinib ASD	XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
DRUG	Omeprazole 40 MG	Omeprazole Delayed Release Capsules, USP 40 mg

Timeline

• Start date: 2020-11-01
• Primary completion: 2020-12-19
• Completion: 2020-12-19
• First posted: 2022-06-27
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study