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

Xspray Pharma

Status and phase: Completed; Phase 1

Conditions: Biological Availability

Treatments: Drug: Dasatinib ASD 100 mg; Drug: Dasatinib 140 MG [Sprycel]

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05439408

XS004-15

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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110 participants in 8 patient groups

XS004 - Period 1

Experimental group

Description:

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.

Treatment:

Drug: Dasatinib ASD 100 mg

SPRYCEL - Period 1

Active Comparator group

Description:

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.

Treatment:

Drug: Dasatinib 140 MG [Sprycel]

XS004 - Period 2

Experimental group

Description:

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.

Treatment:

Drug: Dasatinib ASD 100 mg

SPRYCEL - Period 2

Active Comparator group

Description:

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.

Treatment:

Drug: Dasatinib 140 MG [Sprycel]

XS004 - Period 3

Experimental group

Description:

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.

Treatment:

Drug: Dasatinib ASD 100 mg

SPRYCEL - Period 3

Active Comparator group

Description:

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.

Treatment:

Drug: Dasatinib 140 MG [Sprycel]

XS004 - Period 4

Experimental group

Description:

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.

Treatment:

Drug: Dasatinib ASD 100 mg

SPRYCEL - Period 4

Active Comparator group

Description:

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.

Treatment:

Drug: Dasatinib 140 MG [Sprycel]