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

Xspray Pharma

Status and phase: Completed; Phase 1

Conditions: Drug Interactions; Pharmacokinetics

Treatments: Drug: Dasatinib ASD; Drug: Omeprazole 40 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT05433896

XS004-09

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Dasatinib ASD alone

Experimental group

Description:

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.

Treatment:

Drug: Dasatinib ASD

Dasatinib ASD + Omeprazole

Other group

Description:

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.

Treatment:

Drug: Omeprazole 40 MG

Drug: Dasatinib ASD