Healthy
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGXS003
DRUGTasigna
Sponsors
XSpray Microparticles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability of Nilotinib | 3 days | Pharmacokinetics measured by Area Under the Curve (AUC) |
Countries
United Kingdom
Outcome results
None listed