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

NCT06145217 | Completed Phase 1

• 1 other identifier: XS004-17
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Drug-drug Interaction Study

Outcome Measures

Primary Outcomes (2)

• Drug-drug interaction Plasma Concentration (Cmax)

  To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected. Dasatinib (SPRYCEL®) concentration-time profiles will be evaluated using non-compartmental methods. Peak Plasma Concentration (Cmax) and tmax will be derived from the observed plasma concentration data.

  a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.

• Drug-drug interaction AUC0-t

  To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected. Dasatinib (SPRYCEL®) concentration-time profiles will be evaluated using non-compartmental methods. AUC0-t will be calculated using linear trapezoidal interpolation.

  a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.

Study Arms (1)

SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets

EXPERIMENTAL

To evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole under fasted conditions in healthy, adult, human subjects.

Drug: SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg

Interventions

SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg DRUG

To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole under fasted conditions in healthy, adult, human subjects.

Also known as: dasatinib

SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, human beings 18 and 45 years of age.
• Subjects weighing at least 50 kg for male or 45 kg for female, having a body mass index between 18.5 Kg/m2 and 29.9 Kg/m2.
• Subject must be able to provide written informed consent with a detailed description of nature of the drug.
• Acceptable medical history, physical examination, Electrocardiography (ECG), laboratory investigations within 21 days prior to enrollment and chest X-ray.
• Female subjects must meet one of the following criteria:
• Physiological postmenopausal status, defined as the following. Absence of menses for at least one year prior to the first study drug administration (without an alternative medical condition); and FSH levels ≥40 mlU/mL during screening / at check-in or Surgical postmenopausal status. Must agree to use an adequate method of contraception. Bilateral tubal occlusion or hysterectomy
• Clinical laboratory values should be within the laboratory's stated normal range.
• The subject is able to communicate meaningfully with study personnel and is anticipated to be able to comply fully with study procedures
• Male or Female subjects who participate in the study should agree to practice abstention or contraception during the study and for at least 90 days after the last dose of dasatinib.
• Male subjects should not donate sperm for 90 days from the last administration of IMP.
• Light, Non or ex-smoker

You may not qualify if:

• Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg.
• Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
• Body temperature less than 95.0 °F (35.0 °C) or above 98.6°F (37.0 °C).
• Pulse rate less than 60/min or above 100/min.
• History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
• Any history of impairment of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, or disorder.
• History of hematological, bleeding, and malignant disorders
• History of gastrointestinal disorders that may affect the absorption of the drug, including achlorhydria, hypochlorhydria, hypermotility, hypomotility, malabsorption disorder, diarrhoea, prior bowel resection, colostomy, and ileostomy.
• Subjects with estimated glomerular filtration rate \< 90 mL/minute/1.73 m2 at screening or on the day of check-in.
• History of taking anticoagulant medication, antiarrhythmics and antiplatelet agents.
• A prolonged QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening.
• Volunteer has taken P-gp inhibitors within 30 days prior to the check-in.
• History of any drug or alcohol abuse in the past 2 years.
• History of intake of strong CYP3A4 inhibitors (see Appendix-5) or inducers within 4 weeks prior to the check-in.
• History of intake of drugs known to prolong the QTc interval within 4 weeks prior to the check-in (see Appendix-5).

Sponsors & Collaborators

• Xspray Pharma AB: lead

Study Sites (1)

QPS Bioserve India Pvt Limited

Hyderabad, 500037, India

Location

MeSH Terms

Interventions

Dasatinib

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Maria Klockare

  Xspray Pharma AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label, non-randomized, two-treatment, single-period, single dose, drug-drug interaction study, which allows for independent establishment of the true intrasubject variability for dasatinib

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 24, 2023
• Study Start: August 22, 2023
• Primary Completion: August 22, 2023
• Study Completion: August 29, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)