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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XS003 Dose-level 1 | Experimental | Capsule formulation |
|
| XS003 Dose-level 2 | Experimental | Capsule formulation |
|
| XS003 Dose-level 3 | Experimental | Capsule formulation |
|
| Tasigna | Experimental | Marketed capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XS003 | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of Nilotinib | Pharmacokinetics measured by Area Under the Curve (AUC) | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XSpray Microparticles | XSpray Microparticles | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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| Tasigna | Drug |
|
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