MedDataX Logo

Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions

NCT ID: NCT05439408

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2021-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An open label, single-center, balanced, randomized, two-treatment, two-sequence, four-period, full replicate, crossover, single dose, Phase I, oral comparative bioavailability study in healthy, adult participants (male subjects and female subjects of non-childbearing potential) under fasting conditions with a screening period of 21 days prior to enrollment. In each study period, 21 blood samples were collected from each participant to analyze the pharmacokinetic profile of the test as well as the reference drug.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biological Availability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

XS004 - Period 1

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 100 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel and in accordance with the randomization schedule.

Group Type EXPERIMENTAL

Dasatinib ASD 100 mg

Intervention Type DRUG

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation

SPRYCEL - Period 1

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 140 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel, and in accordance with the randomization schedule.

Group Type ACTIVE_COMPARATOR

Dasatinib 140 MG [Sprycel]

Intervention Type DRUG

SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets

XS004 - Period 2

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 100 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel and in accordance with the randomization schedule.

Group Type EXPERIMENTAL

Dasatinib ASD 100 mg

Intervention Type DRUG

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation

SPRYCEL - Period 2

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 140 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel, and in accordance with the randomization schedule.

Group Type ACTIVE_COMPARATOR

Dasatinib 140 MG [Sprycel]

Intervention Type DRUG

SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets

XS004 - Period 3

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 100 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel and in accordance with the randomization schedule.

Group Type EXPERIMENTAL

Dasatinib ASD 100 mg

Intervention Type DRUG

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation

SPRYCEL - Period 3

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 140 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel, and in accordance with the randomization schedule.

Group Type ACTIVE_COMPARATOR

Dasatinib 140 MG [Sprycel]

Intervention Type DRUG

SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets

XS004 - Period 4

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 100 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel and in accordance with the randomization schedule.

Group Type EXPERIMENTAL

Dasatinib ASD 100 mg

Intervention Type DRUG

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation

SPRYCEL - Period 4

At the clinic, after an overnight fast of at least 10 hours, a single oral dose of 140 mg tablet was administered to each participant in a sitting posture with about 240 mL of drinking water in the presence of the principal investigator and quality assurance personnel, and in accordance with the randomization schedule.

Group Type ACTIVE_COMPARATOR

Dasatinib 140 MG [Sprycel]

Intervention Type DRUG

SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dasatinib ASD 100 mg

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation

Intervention Type DRUG

Dasatinib 140 MG [Sprycel]

SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy males (sterile or using contraception) or females of non-childbearing potential 18 and 55 years of age
* Acceptable medical history, physical examination, laboratory investigations within 21 days prior to enrollment
* Clinical laboratory values were within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator
* The subject is able to communicate meaningfully with study personnel and is anticipated to be able to comply fully with study procedures

Exclusion Criteria

* Any history of impairment of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or disorder
* Participated in any other clinical study or donated blood in last 90 days
* Positive screens for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody (HepC) or human immunodeficiency virus (HIV)
* Female subjects demonstrating a positive pregnancy screen, currently breastfeeding or using hormone replacement therapy within three months prior to dosing of test product
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

QPS Bioserve India Pvt Limited

UNKNOWN

Sponsor Role collaborator

Xspray Pharma AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Per Andersson, PhD

Role: STUDY_DIRECTOR

Xspray Pharma AB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

QPS Bioserve India Pvt Limited

Hyderabad, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XS004-15

Identifier Type: -

Identifier Source: org_study_id