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

NCT05433896 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-06-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Axis Clinicals Limited

    collaborator INDUSTRY

  • Xspray Pharma AB

    lead INDUSTRY

Principal Investigators

  • Per Andersson, PhD · Xspray Pharma AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2020-12-19
Completion
2020-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05433896 on ClinicalTrials.gov