Pharmacokinetic Comparison of XS003 and Tasigna

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: XSpray Microparticles

Criteria

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)