NCT06145217

An Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL®

Open-label, Non-randomized, Two-treatment, Single-period, Single Dose, Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL® 100 mg Film-coated Tablets (Dasatinib) in Adult Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Xspray Pharma AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects

Detailed description

A drug-drug interaction study and was designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart. 18 healthy, adult, human subjects were enrolled into the study. Forty (40) PK blood sampling time points and a washout period of 05 days (between two administration of the study drug SPRYCEL® 100mg) were planned so that the drug concentration in the biological fluid could be characterized accurately for this drug interaction study.

Conditions

• Drug-drug Interaction Study

Interventions

Type	Name	Description
DRUG	SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg	To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole under fasted conditions in healthy, adult, human subjects.

Timeline

• Start date: 2023-08-22
• Primary completion: 2023-08-22
• Completion: 2023-08-29
• First posted: 2023-11-24
• Last updated: 2023-11-24

Locations

1 site across 1 country: India