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

NCT ID: NCT05433896

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2020-12-19

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dasatinib ASD alone

At the clinic, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 1 after an overnight fast of at least 9 hours. Dasatinib was given with approximately 240 mL of room temperature water. Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served.

Group Type: EXPERIMENTAL

Dasatinib ASD

Intervention Type: DRUG

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation

Dasatinib ASD + Omeprazole

At the clinic, on Day 2 to Day 6, participants were administered a single oral dose of Omeprazole 40 mg × 1 Delayed Release Capsule once before meals in the evening with approximately 150 mL of room temperature water. No food was allowed two hours before and one hour after administration of Omeprazole.

In addition, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 6 after an overnight fast of at least 9 hours. Dasatinib was given with approximately 240 mL of room temperature water. Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served.

Group Type: OTHER

Dasatinib ASD

Intervention Type: DRUG

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation

Omeprazole 40 MG

Intervention Type: DRUG

Omeprazole Delayed Release Capsules, USP 40 mg

Interventions

Dasatinib ASD

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation

Intervention Type: DRUG

Omeprazole 40 MG

Omeprazole Delayed Release Capsules, USP 40 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: 18-60 years
• Sex: Healthy adult males (sterile or using contraception) and females of non-childbearing potential
• Clinical laboratory values should be within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator
• No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by the Investigator
• Any abnormalities/deviations from the acceptable range of medical history, laboratory values, ECG, and vital signs that might be considered clinically relevant by the study physician or Investigator will be evaluated as individual cases
• Able to comply with study procedures, in the opinion of the Investigator(s)
• Willing to give written consent, pregnancy outcome consent, and adhere to all the requirements of this protocol

Exclusion Criteria

• Any major illness in the last three months or any significant ongoing chronic medical illness
• Does not agree to consume the provided meals
• Participation in any clinical trial 30 days prior to dosing
• Positive results for drugs of abuse or alcohol breath analysis prior to dosing
• Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen, Hepatitis C Virus, or anti-HBc tests
• Females currently breastfeeding, demonstrating a positive pregnancy screen, or using hormone replacement therapy within three months prior to dosing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Axis Clinicals Limited

INDUSTRY

Sponsor Role: collaborator

Xspray Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Andersson, PhD

Role: STUDY_DIRECTOR

Xspray Pharma AB

Locations

AXIS Clinicals

Dilworth, Minnesota, United States

Countries

United States

Other Identifiers

XS004-09

Identifier Type: -

Identifier Source: org_study_id