Pharmacokinetic Comparison of XS003 and Tasigna

XSpray Microparticles

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: XS003; Drug: Tasigna

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068898

XS003_CT001

Details and patient eligibility

About

The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.

Full description

The study consists of two parts, the first part is composed as a pilot part and compares the bioavailability of single oral doses of XS003 compared to Tasigna® given as single oral dose in healthy male subjects. The second part is a food-effect part which assesses the food effect of a single oral dose of XS003 in healthy male subjects either fed or fasted. The study will also evaluate safety and tolerability of XS003 as secondary objectives.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males
• Age 18 to 55 years of age
• Body mass index (BMI) of 18.0 to 29.0 kg/m2
• Laboratory parameters in normal range

Exclusion criteria

• Females
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening.
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator.
• Subject has a QTcF>450 ms based on ECG at screening or a history of additional risk factors for Torsades de Pointe (e.g. hypokalaemia, hypomagnesemia, a family history of long QT syndrome)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

XS003 Dose-level 1

Experimental group

Description:

Capsule formulation

Treatment:

Drug: XS003

XS003 Dose-level 2

Experimental group

Description:

Capsule formulation

Treatment:

Drug: XS003

XS003 Dose-level 3

Experimental group

Description:

Capsule formulation

Treatment:

Drug: XS003

Tasigna

Experimental group

Description:

Marketed capsule

Treatment:

Drug: Tasigna